CN103987410B

CN103987410B - Systems and methods for controlling operation of reduced pressure therapy system

Info

Publication number: CN103987410B
Application number: CN201180073693.1A
Authority: CN
Inventors: J.阿伦; B.A.阿斯克姆; S.J.科林森; R.休伊; D.尼科利尼
Original assignee: Smith and Nephew PLC
Current assignee: Smith and Nephew PLC
Priority date: 2011-07-26
Filing date: 2011-11-02
Publication date: 2017-05-03
Anticipated expiration: 2031-11-02
Also published as: CN105749363B; JP2017131725A; EP3622976A1; ZA201400793B; RU2596728C2; EP2736547A2; JP2014526924A; MX2014000998A; BR112014001884A2; CA2843133A1; RU2016132417A; RU2014106899A; AU2011373654A8; WO2013015827A3; CN105749363A; ES2754252T3; JP6131253B2; CA2843133C; BR122014027005A2; CN103987410A

Abstract

Negative pressure wound therapy apparatuses and dressings, and systems and methods for operating such apparatuses for use with dressings are disclosed. In some embodiments, controlling the delivery of therapy can be based on monitoring and detecting various operating conditions. An apparatus can have a controller configured to monitor the duty cycle of a source of negative pressure and, based on the monitored duty cycle, determine whether a leak is present. The controller can be configured to provide an indication that a leak is present. For example, the controller can be configured to suspend and/or pause the delivery of therapy, and to restart the delivery of therapy due to a timeout, request from a user, etc. In addition, the controller can be configured to pause and/or restart the delivery of therapy upon a request from the user, such as in response to the user operating a switch.

Description

System and method for controlling the operation of Reduced pressure treatment system

Cross-Reference to Related Applications

This application claims U.S. Provisional Patent Application No. 61/511,950 submitted on July 26th, 2011 is preferential Power, the disclosure of which are incorporated by reference herein in its entirety.Additionally, that what is submitted on November 2nd, 2011 is entitled " REDUCED PRESSURE THERAPY APPARATUSES AND METHODS OF USING SAME " (pressure reduction therapy equipment And its using method) co-pending patent application No. 13/XXX, XXX (attorney SMNPH.195A) and in Entitled " the REDUCED PRESSURE THERAPY APPARATUSES AND METHODS OF that on November 2nd, 2011 submits to The co-pending international patent application No. PCT/US2011/ of USING SAME " (pressure reduction therapy equipment and its using method) The disclosure of XXXXXX (attorney SMNPH.195WO) is incorporated by reference herein in its entirety.

Technical field

Presently disclosed embodiment be related to for using local decompression (TNP) treat dressing and process wound method and Equipment.Such as but not limited to, some embodiments disclosed herein relates to the use of the decompression provided from pump block part processing wound. Although not required, but some embodiments of pump block part can be aseptic.It is as another non-limiting example, disclosed herein Some embodiments be related to for controlling the apparatus and method of the operation of TNP systems.

Background technology

Become known for many different types of wound dressing of the agglutination of auxiliary human or animal.These are different types of Wound dressing includes many different types of materials and layer, such as gauze, pad, foam pad or multilayered wound dressing.Local decompression (" TNP ") treatment is sometimes referred to as vacuum assisted closure, negative pressure wound therapy or reduced pressure wound therapy, and which is broadly considered For improving the beneficial mechanisms of wound healing speed.Such treatment is suitable for various wounds, such as otch, open wound Wound and trauma of abdomen etc..

TNP treatments are by reducing tissue edema, promoting blood flow, the formation for stimulating granulation tissue, removing excessive oozing Go out closure and healing that thing carrys out assist wound, and bacterial load and therefore infection of the reduction to wound can be reduced.And, TNP treatments can reduce the external disturbance of wound and promote faster to heal.

The content of the invention

Some embodiments disclosed herein is related to a kind of pump group part for reduced pressure wound therapy, and which includes shell, props up Support the pump in inside the shell or by shell support, the flow channel by pump group part and be in fluid communication and supported by shell with pump Style one-way flow valve.Some embodiments of style one-way flow valve are configurable to substantially prevent gas in the direction flowed away from pump It is upper to cross flow channel.Pump can have：Motor；Entrance and exit；First valve, its by pump support and be configured to control pass through into The flowing of the fluid of mouth；And second valve, which is supported by pump and is configured to control the flowing of the fluid by outlet.

Some embodiments disclosed herein is related to a kind of pump group part for reduced pressure wound therapy, and which includes shell, props up Support the style one-way flow valve and the flow channel by pump group part of the pump and pump fluid communication supported in inside the shell or by shell. Style one-way flow valve is configurable to substantially prevent gas from flowing flow channel on the direction flowed away from pump.Pump may include horse Up to, entrance and exit.In any one pump embodiment disclosed herein, although it is not required that, but pump also can have be configured to First valve of the flowing of fluid of the control by entrance and the second valve of the flowing for being configured to control the fluid by outlet.Herein Some disclosed pump embodiments can control flowing or the flow rate of the fluid by pump using aperture or further feature or part.

Some embodiments disclosed herein is related to a kind of negative pressure treatment external member for reduced pressure wound therapy, and which includes： Pump group part, its controller for including shell, the pump for being supported on inside the shell and being supported on inside the shell or supported by shell；And At least one switch supported by shell or button.As used by this specification, phrase " some embodiments " or " In a little embodiments " mean described, illustrating, being incorporated by reference, or appointing in this article otherwise disclosed What embodiment.At least one switch or button can be communicated with controller and can be touched by user, to allow user One or more operator schemes of controlling pump.But negative pressure treatment external member may include in certain embodiments, although it is not required that,：Apply Material, which is configured to substantially fluid-tight sealing is formed on wound；Conduit, can be coupled with dressing and pump group part and by structure Cause to provide the fluid flowing passage substantially or entirely closed from pump group part to dressing；And first packaging element, it is used for Packaging pump group part, one or more battery, dressing and conduit.In certain embodiments, controller be configurable to controlling pump and The operation of valve.Some embodiments of negative pressure treatment external member can be configured so that negative pressure treatment external member is sterilized.Negative pressure treatment External member can be sterilized cause at least inside and outside of shell, at least one valve, pump, controller and at least one switch or Button is sterilized.In certain embodiments, pump can have：Pump motor；Entrance and exit；At least one valve, which is configured to Flowing of the control by the fluid of at least one of entrance and exit；And by least entrance, outlet and at least one valve Flow channel.

Some embodiments disclosed herein relates to the use of the wound reduced pressure treatment that drawdown pump is carried out.Pump disclosed herein Embodiment need not be sterilized.However, sterilizing to drawdown pump and aseptically providing pump and/or dressing or pump using front Set components can allow any other place of the aseptic of or claimed apparatus interior in operating room (also referred to as operating room) to use Pump.For example and it is not limited to, some embodiments are related to a kind of aseptic pump block part, which includes aseptic pump, aseptic dressing and can be in handss The sterile catheter that may be connected to dressing and pump used in art room.

Some embodiments disclosed herein is related to a kind of negative pressure treatment external member for reduced pressure wound therapy, and which includes tool There are the pump and the dressing including coating of about 350 ml/mins or following flow rate.Dressing can have with the bonding of organic silicon substrate The wound contact surface that agent is covered.

Some embodiments disclosed herein is related to a kind of tank-less pump for reduced pressure wound therapy, and which includes：It is shell, logical One or more valves and the pump for being supported on inside the shell or being supported by shell that the flow channel and flow channel for crossing pump is connected, Wherein pump is tank-less.Some embodiments disclosed herein is related to a kind of tank-less pump group part for reduced pressure wound therapy, its Including shell and the pump for being supported on inside the shell or being supported by shell.Pump can have：Motor；Entrance and exit；First valve, which is by pump Support and be configured to control the flowing of the fluid by entrance；And second valve, which is supported by pump and to be configured to control logical Cross the flowing of the fluid of outlet.Pump or pump group part can be tank-less.Additionally, although it is not required that, but for disclosed herein For all embodiments, the first and second valves can with nominal operating pressure and/or during nominal sterilization pressure from The leak rate of about 0.1mL/ minutes to about 10mL/ minutes, or from 0.1mL/ minutes or with down to 5mL/ minutes or more, Or from 1mL/ minutes or with down to 3mL/ minutes or more, or in any one under nominal operating pressure in aforementioned range Leak rate between any two value.In certain embodiments, leak rate can be under nominal operating pressure and/or From about 0.4mL/ minutes to 0.7mL/ minutes during nominal sterilization pressure.

Some embodiments of pump group part can have piezoelectric pump, such as but not limited to US 7,550,034 and/or US 2011/ Piezoelectric pump disclosed in 186765.Some piezoelectric pumps can have the aperture for being used to performing valve function so that when pump rest, pass through The flow rate of pump may be up to 200mL/ minutes.Therefore, wherein pump flow rate may be up to about 300mL/ minutes or 320mL/ minutes or Other, the first and second valves (which can be aperture) can each have up to about 200mL/ minutes leak rate.

Some embodiments disclosed herein is related to a kind of aseptic pump block part, and which includes：Pump embodiment disclosed herein In any one；Dressing；Conduit, its pressure reducing fluid that can be coupled and be configured to provide dressing with dressing and aseptic pump are led to Road；One or more battery；And first packaging element and be configured to the first packaging element removedly couple second wrap Dress element.In certain embodiments, at least one of first and second packaging elements can have for receiving aseptic pump, applying Material, the recess of conduit, the conduit can be coupled with dressing and aseptic pump and be configured to provide the pressure reducing fluid passage of dressing. Pump, dressing, conduit and one or more battery have been supported at least one of the first packaging element and the second packaging element After portion, aseptic pump block part can be carried out disinfection.

Some embodiments disclosed herein is related to a kind of method for starting treatment of wounds in situations in the surgery room, its bag Include：Apply aseptic dressing on wound, so that substantially fluid-tight sealing is formed on wound；By aseptic pump via aseptic Conduit is connected to dressing；And reduce the press water between dressing and wound in situations in the surgery room by starting pump in situations in the surgery room It is flat.

Some embodiments disclosed herein is related to for controlling the apparatus and method of the operation of negative pressure wound treating system. It is particularly, but without limitation, to, presently disclosed embodiment is related to negative pressure treatment equipment and dressing and for operating such negative pressure The method and algorithm for the treatment of system.But equipment may include such dressing in certain embodiments, although it is not required that,：Which is by structure Cause to be placed on wound and formed on wound the sealing of basic upper fluid impermeable.Equipment may include to be configured to connection To the negative pressure source of dressing.The equipment may also include controller, and the controller is configured to start negative pressure source, monitors accounting for for negative pressure source Empty ratio, and determine whether dutycycle exceeds duty cycle threshold.In certain embodiments, controller is configurable in multiple companies Multiple dutycycles of monitoring negative pressure source and whether the dutycycle in determining multiple dutycycles surpasses in the continuous and equal persistent period Go out duty cycle threshold.When dutycycle can be reflected in a time period or in the multiple continuous and equal persistent period and continue Time quantum of the interior negative pressure source in activity.

In certain embodiments, controller be configurable to determine the dutycycle of a quantity whether beyond duty cycle threshold with And whether the quantity exceeds overloading threshold.In certain embodiments, controller is configurable to determine from multiple dutycycles Whether one group of dutycycle exceeds duty cycle threshold and determines whether the quantity of dutycycle in this set exceeds overloading threshold.Control Device processed is configurable to determine whether the quantity of the dutycycle beyond duty cycle threshold is continuous.In certain embodiments, mistake Carrying threshold value may include that 30 dutycycles, time period or persistent period may include one minute, and/or duty cycle threshold may include 9%. In certain embodiments, controller is configurable to continuously monitor dutycycle or multiple dutycycles.

Some embodiments of equipment include being configured to by negative pressure source suspend a time period switch and may be configured to this when Between section restart the controller of negative pressure source when expiring.Time period can be variable.In certain embodiments, equipment can be enclosed in bag Include in the shell of outer surface, and switch includes the button on the outer surface of shell.

Some embodiments of equipment include the controller of the instruction for being configured to provide mode of operation.Mode of operation may include really Dutycycle is determined beyond duty cycle threshold, and indicate to may include to disable negative pressure source with the leakage in indicating sealing.In some enforcements In example, mode of operation includes whether negative pressure source is suspended, and controller is configurable to provide when negative pressure source is in activity First indicates and second is provided when negative pressure source is suspended to indicate, wherein second indicates to indicate different from first.

In certain embodiments, controller is configurable to：Start negative pressure source and born with attempting the expectation produced below dressing Voltage levels, and if the stress level when the very first time, interval was expired below dressing not up to expects pressure-reduction level, control Negative pressure source can be disabled the second time interval by device.When the second time interval is expired, controller can start negative pressure source to attempt producing Expectation pressure-reduction level below raw dressing.Controller is configurable to the stress level below according to dressing and not up to expects negative pressure The number of times of level is changing the second time interval.For example, be configurable to will be the second time interval double for controller, precondition It is income value without departing from the second interval threshold.The equipment may include sensor, and which is configured to the pressure below sensing dressing simultaneously By the pressure communication for sensing to controller.

In certain embodiments, controller is configurable to the stress level below the dressing and has reached expectation pressure-reduction level When disable the negative pressure source and stress level below dressing starts negative pressure source when rising to more than negative threshold, wherein expecting negative Voltage levels are corresponding to than the more negative pressure of negative threshold.

In certain embodiments, negative pressure source can be operated in the following manner：Dressing is positioned on wound with wound Form the sealing of basic upper fluid impermeable；Negative pressure is delivered to into dressing from negative pressure source；The dutycycle of monitoring negative pressure source；And It is determined that dutycycle provides instruction when exceeding duty cycle threshold.Dutycycle can be reflected in negative pressure source in a time period and be in activity Time quantum, for example it is per minute once.

Some embodiments of equipment are configurable to total time-consuming of the monitoring from initial start and when total time-consuming reaches the longevity The startup of negative pressure source is disabled during life threshold value.Lifetime threshold may include such as 7 days.

In certain embodiments, the equipment for negative pressure to be applied to wound includes：Dressing, which is configured to be placed on wound The sealing of basic upper fluid impermeable is formed on mouth and on wound；Negative pressure source, which is configured to couple to dressing；And control Device processed, which is configured to start negative pressure source, the dutycycle of monitoring negative pressure source and provide when dutycycle exceeds duty cycle threshold refer to Show.

In certain embodiments, equipment includes：Dressing, which is configured to be placed on wound and is formed on wound basic The sealing of upper fluid impermeable；And pump, which is configured to couple to dressing；Switch, which is configured to suspend for the moment pump Between section；And controller, which is configured to restart pump when expiring the time period.Time period can be variable.The one of equipment The Miniature diaphragm pump that a little embodiments include the Miniature diaphragm pump operated by motor or operated by piezoelectric transducer.In some embodiments In, pump may include micro-piston pump and Miniature diaphragm pump.

Some embodiments disclose a kind of method of operation negative pressure source (for example, negative pressure pump), and the method includes：Dressing is fixed Position is on wound so that the sealing of basic upper fluid impermeable is formed on wound；Negative pressure is delivered to into dressing from pump；Pump is temporary Stop a time period；And pump is restarted when expiring the time period.Time period can be variable.

In certain embodiments, negative pressure pump can be operated in the following manner：Dressing is positioned on wound with wound Form the sealing of basic upper fluid impermeable；Fluid is suctioned out from wound using negative pressure pump；The level of activation of measurement pump；By pump Level of activation is compared with threshold value；And instruction is provided when level of activation exceeds threshold value.Measurement level of activation may include：It is determined that The dutycycle of pump；It is determined that the flow rate (for example, by using effusion meter) of the fluid suctioned out from wound；Surveyed using pressure transducer etc. The rate of change of the pressure below amount dressing；Or any combination of them.

Some embodiments disclose a kind of method of operation negative pressure pump, and which includes：Dressing is positioned on wound with wound The sealing of basic upper fluid impermeable is formed on mouth；Negative pressure is delivered to dressing from pump to apply to arrange towards the first negative pressure set point The pressure of material lower section；When the pressure-reduction level below dressing rises to more than second negative pressure set point, start pump to set towards first Fixed point arranges the pressure below dressing；The time quantum that monitoring pump has been operated；And carry when the time quantum exceeds predetermined time amount For indicating.The method may also include：It is determined that the time quantum that pump has been operated within the time period and when the time quantum exceeds this Between section 9% when instruction is provided.In certain embodiments, there is provided when indicating also to include to determine that within time period pump operated The area of a room.In certain embodiments, there is provided indicate also to include starting alarm.

In certain embodiments, equipment is configurable to start negative pressure source with by the pressure below the negative pressure wound treatment dressing Power is arranged to expecting negative pressure value, such as between the first set point and the second set point or be approximately equal to the value of the second set-point value. Stress level below dressing can be measured.(for example, equipment is configurable to more than the decline of pressure below dressing to threshold value Decay to the first set-point value) when start negative pressure source with towards second expect pressure-reduction level (for example, the second set-point value) arrange apply The pressure of material lower section.The time quantum of negative pressure source such as operates continuously can be monitored.Predetermined time amount has been operated in negative pressure source And when not setting up the second expectation pressure-reduction level (for example, the second set-point value) below about dressing, the operation of negative pressure source can quilt Suspend or interrupt.

Some embodiments disclose a kind of method of operation negative pressure source, and which includes：Dressing is positioned on wound with wound The sealing of basic upper fluid impermeable is formed on mouth；And negative pressure is delivered to into dressing from negative pressure source.By negative pressure from negative pressure source Being delivered to dressing includes：Start negative pressure source with attempt produce dressing below expectation pressure-reduction level and update the first startup counting； If the negative pressure when the very first time, interval was expired below dressing not up to expects pressure-reduction level, negative pressure source was disabled into for the second time Interval, precondition are that the first startup counting retries threshold value less than first；If first starts counting retries threshold not less than first Negative pressure source is disabled the 3rd time interval by value；Reset first and start counting, and when the 3rd time interval is expired, start negative Potential source with attempt produce dressing below expectation pressure-reduction level；Start negative pressure source to attempt producing when the second time interval is expired Expectation pressure-reduction level below dressing, and update the first startup counting；Negative pressure below dressing reaches expectation negative pressure water At ordinary times, negative pressure source is disabled, resets first and start counting, and monitor the negative pressure below dressing；Negative pressure below dressing rises During to more than negative threshold, start negative pressure source and update the second startup counting, wherein expecting pressure-reduction level corresponding to than negative pressure The more negative pressure of threshold value；If the negative pressure before the 4th time interval is expired below dressing has reached expectation pressure-reduction level, stop With negative pressure source, the negative pressure below dressing is monitored, and resets the second startup counting；If the dressing when the 4th time interval is expired The negative pressure of lower section not up to expects pressure-reduction level, and negative pressure source is disabled the second time interval, and precondition is that the second startup is counted Threshold value is retried less than second；If second starts counting retries threshold value not less than second, negative pressure source is disabled into the 3rd time interval, Reset second and start counting, and when the 3rd time interval is expired, start negative pressure source to attempt producing the expectation below dressing Pressure-reduction level and update the first startup counting；The dutycycle of negative pressure source is monitored continuously；Tracking is accounted for beyond duty cycle threshold The quantity of empty ratio；And when the quantity of the dutycycle beyond duty cycle threshold exceeds overloading threshold, negative pressure source is disabled into the 3rd The persistent period of time interval.

Description of the drawings

Various embodiments of the present invention only will be described by way of example with reference to the accompanying drawings hereinafter now, in the accompanying drawings：

Fig. 1 illustrates the embodiment of reduced pressure wound therapy equipment, and which includes pump, dressing and conduit.

Fig. 2A -2F are the various views of the embodiment of the pump illustrated in Fig. 1.

Fig. 3 A illustrate the embodiment of wound dressing external member, and which includes the dressing being supported in the first packaging element, pump, leads Pipe, two batteries and one or more sealing strips.

Fig. 3 B are the face upwarding stereograms of the embodiment of the wound dressing external member of Fig. 3 A.

Fig. 3 C are the exploded views of the embodiment of the wound dressing external member of Fig. 3 A.

Fig. 4 A are the first exploded views of the embodiment of the pump of Fig. 1.

Fig. 4 B are the second exploded views of the embodiment of the pump of Fig. 1.

Fig. 5 A and Fig. 5 B are the first and second views of the first casing component.

Fig. 6 A and Fig. 6 B are the first and second views of second housing component.

Fig. 7 A-7D illustrate that the embodiment of TNP wound treatment systems is used to process the purposes of the wound location with patient.

Fig. 8 A-20H are the top perspective view of the embodiment of packaging element, face upwarding stereogram respectively, plan view from above, look up Plane graph, front view, rearview, the first side view and the second side view, the packaging element can be used for wound disclosed herein Any one in the embodiment of applicator device, including various various sizes of wound dressing equipment.

Figure 21 illustrates the pump group part according to some embodiments.

Figure 22 illustrates the sectional view of the inside for showing the pump group part according to some embodiments.

Figure 23 illustrates the system schematic of the pump group part according to some embodiments.

Figure 24 illustrates the electric component schematic diagram of the pump group part according to some embodiments.

Figure 25 illustrates the top level status figure of the operation of the pump group part according to some embodiments.

Figure 26 illustrates the mode of operation figure of the operation of the pump group part according to some embodiments.

Figure 27 illustrates another state diagram of the operation of the pump group part according to some embodiments.

Figure 28 illustrates the figure that the dutycycle for describing the pump group part according to some embodiments determines.

Figure 29 illustrates the operation of the pump group part in the case where there is low leakage according to some embodiments.

Figure 30 illustrates the operation of the pump group part in the case where there is high-leakage according to some embodiments.

Figure 31 illustrates the operation of the pump group part in the case where there is very high-leakage according to some embodiments.

Figure 32 illustrates the operation of the pump group part in the case where there is high leakage according to some embodiments.

In the accompanying drawings, identical reference represents identical part.

Specific embodiment

Presently disclosed embodiment relates to the use of the apparatus and method of the pressure treatment wound of reduction.As used herein, The stress level or pressure-reduction level of the reduction of such as-XmmHg represents normal atmosphere pressure below level, normal atmosphere pair Should be in 760mmHg (or 1atm, 29.93inHg, 101.325kPa, 14.696psi etc.).Therefore, the negative pressure value reflection of-XmmHg The absolute pressure of XmmHg fewer than 760mmHg, or the in other words absolute pressure of (760-X) mmHg.Additionally, than XmmHg " less " Or the negative pressure of " less " is corresponding to the pressure (for example, -40mmHg is less than -60mmHg) closer to atmospheric pressure.Than-XmmHg " more It is many " or " bigger " negative pressure corresponding to the pressure (for example, -80mmHg be more than -60mmHg) further from atmospheric pressure.

Some in embodiment include pump and/or pump and dressing external member.Some embodiments be related to such pump and/or pump with Dressing external member：It is provided to hospital, operating room or operating room or medical practitioner using such device before disappeared Poison so that aseptic pump and/or aseptic pump/dressing external member can be applied after surgical operation or operative procedure immediately.Such one Individual advantage is：Surgeon can allow patient to leave operating room, and know that drawdown pump is just being operated and decompression treatment is can Time point that can be earliest starts.The another advantage for applying dressing external member after surgical operation or other programs immediately is, this Sample does otherwise can may be needed the follow-up change of dressing for carrying out in ward by elimination and reduce the chance of infection.In other words, For those apply dressing (but not being pump) and then pinpoint the problems (for example, leakage or to ask with regard to other of dressing in operating room Topic) patient for, if needing to remove after patient leaves operating room dressing to reposition, change or carry out other behaviour Make, then when dressing is repositioned, changes or carries out other operations outside operating room, the wound of patient can suffer from infecting wind Danger.However, presently disclosed embodiment is utilized, if applying when patient is in operating room and testing pump, it may be necessary to will Dressing removes, repositions or carry out any problem relevant with dressing of other operations can be in aseptic operating room environment Process, so as to significantly reduce or eliminate the risk for being exposed to pathogen, antibacterial or other pollutant.Additionally, hospital generally can not Which can be carried out disinfection after conventional pump is by hospital's reception, therefore hospital may resort to and pump is wrapped in sterile bag, but But the risk for jeopardizing operating room gnotobasiss because of this method is faced, is particularly unlocked in device and is likely to be present in pump After internal pathogen, antibacterial or other pollutant are released due to the operation of pump.

In certain embodiments, pump be configurable to be amenable to gas depoisoning, with making pump be amenable in all portions of pump Feature, part and other characteristics of sufficient sterilizing gas exposure and infiltration are carried out in part.For example it is not limited to, one or more Pump valve has been chosen or has been configured to allow for enough sterilizing gas stream to flow through from which so that the whole fluid passage in pump can expose In sterilizing gas.As explained in more detail below, in certain embodiments, pump can have other parts, for example, be not limited to The style one-way flow valve for strategically positioning, with other valves in make-up pump, this is by reducing by the fluid passage in pump group part Leakage and the efficiency of pump can be improved.

In addition, when providing, aseptic pump/dressing external member can also be designed and configured to be amenable to gas depoisoning.It is as follows Described, aseptic pump/dressing external member can be configured so that all parts of the pump/dressing external member for constituting aseptic（Including pump group Part）All it was packaged together in before sterilization at least the first packaging element, to allow all parts to sterilize together.And, such as will To be described, the part for constituting aseptic pump/dressing external member is may be arranged in packaging so that at least some in part can be with pre- Fixed order is removed so that surgeon or medical practitioner easily assemble and dressing is applied to patient.

Can start to process wound in operating room has many benefits, including but not limited in wound in will suppress or prevent Antibacterial or other pollutant provide substantially sealed barrier on wound while entering in the aseptic condition and environment of wound. In addition, causing reduced pressure treatment to be also beneficial to the healing of wound in the stage as earliest as possible.

In addition, disclosed or incorporated herein by reference embodiment, such as U.S. Patent application No. 13/092, 042nd, UK Patent Application No. 1015656.0, No. 1006986.2, No. 1006983.9, No. 1006985.4, No. Those disclosed in 1006988.8 and No. 1008347.5, all including improved wound dressing member.It is such disclosed all Embodiment, part, feature and other details are incorporated herein by reference just as constituting a part of this disclosure, and Any one part, feature and other details of presently disclosed embodiment can be replaced to use or be used in combination with them.Example Such as, in certain embodiments, wound dressing is configurable to serve as buffer to contribute to preventing for example as patient moves Wound in the compression stress being applied on wound dressing or shearing force injury healing.The embodiment of wound dressing may act as waste cylinder To collect and store from wound location the Wound exudate for removing, and it is directed to applying when TNP is treated to covering wound portion The management of the solids bulk thing in the wound dressing of position.Additionally, presently disclosed embodiment is related to for applying to wound dressing Plus the method for the method and suction ports and manufacture suction ports and wound dressing of negative pressure.

Additionally, some embodiments disclosed herein is related to include the system of negative pressure treatment equipment and dressing and for grasping The method for making such negative pressure treatment equipment to be used together with negative pressure treatment dressing and algorithm.In certain embodiments, negative pressure Therapeutic equipment includes being configured to especially provide pump group part of the negative pressure to wound.Some embodiment bags of pump group part disclosed herein Include the control logic that is novel and having novelty of the operation for being configured to control pump group part.For example, some embodiments include novelty and There is the control logic of novelty, which is configured to the operation of pump group part be controlled in response to monitoring and detecting various modes of operation, The mode of operation is, for example, the existence and/or seriousness of one or more leakage in system, the fluid (example suctioned out from wound Such as, air, liquid and/or solid exudate etc.) flow rate etc..In certain embodiments, control logic is configurable to detection (for example, one or more in the dressing being in fluid communication with pump is leaked, is being existed by dressing one or more leakage in system One or more in the sealing formed on wound leakage etc.) and when such one or more leakage is detected controlling pump The operation of component.In certain embodiments, pump group part is configurable at least normal or low leakage (for example, with relatively low Flow rate leakage), high-leakage (for example the leakage, with relatively high flow rate), and very high-leakage (for example, with relative The leakage of the very high flow rate in ground) between distinguished.Some embodiments are also configured to also in above-mentioned leakage and high Distinguished between leakage.

In certain embodiments, pump group part may include negative pressure source, for example by such as battery source power source energy supply it is miniature Disposable pump.Pump group part is configurable to provide and continues about 1 day, the treatment of the predetermined amount of time of 2-10 days etc..One In a little embodiments, it may be necessary to which pump group part is providing the uninterrupted treatment of persistently such time period.In certain embodiments, pump Component is configurable to its own is disabled predetermined time period (for example, 7 days) after the initial startup.Calculation disclosed herein Method or logic can help pump group part more efficiently to operate and save power, the such as but not limited to power of battery.

In certain embodiments, pump group part is configurable to the dutycycle for monitoring negative pressure source (for example, pump).Such as this paper institutes With " dutycycle " reflects the time quantum that negative pressure source is movable within a time period or runs.In other words, dutycycle reflects negative pressure The time of the fraction as the total time for being considered that source is active.This can be expressed as by mathematical way：

DC = t/T, (1)

Wherein, DC is dutycycle, and t is persistent period of the negative pressure source in activity, and T is by total time for considering.Account for Sky is than measurable for absolute value (for example, X seconds), ratio (for example, 1/X), percentage ratio (for example, X%) etc..For example, if at 1 point In the time period of clock, negative pressure source has turned on (or operation) 6 seconds and closes (or not operating) 54 seconds, then dutycycle is represented by 6 Second, 1/10,10% etc..

In certain embodiments, pump group part may include the controller of the dutycycle for being configured to monitor negative pressure source.Dutycycle is surveyed Value can reflect the level of activation of negative pressure source.For example, dutycycle may indicate that negative pressure source in normal operating, intensive work, high Intensity ground work etc..Additionally, such as regularly the duty ratio measuring value of duty ratio measuring value can reflect various modes of operation, for example The existence leaked in system and/or seriousness, the fluid (for example, air, liquid and/or the solid exudate that suction out from wound Deng) flow rate etc..According to duty ratio measuring value, such as by comparing the dutycycle of measurement with one group of threshold value (for example, in demarcation It is determined that), controller it is executable and/or be programmed to execute according to various system requirements come control system operation algorithm or Logic.For example, duty ratio measuring value may indicate that the presence of high-leakage in system, and controller can be programmed to user (for example, patient, nursing staff, doctor etc.) indicates the state and/or interim termination or suspends the operation of negative pressure source with energy-conservation.

In certain embodiments, system is configurable to by any other suitable device monitor flow rate.Pump group part Be configurable to using effusion meter (for example, mechanical meters, based on the effusion meter of pressure, optical flow meter, mass flowmenter, Thermal mass flow meter, electromagnetic flowmeter, acoustic wave flow meter, ultrasonic flowmeter, laser Doppler flowmeter etc.), anemometer, Pressure transducer or sensor, electromagnetic transducer (for example, being configured to measure the sensor of pump speed, such as Hall element), Electromagnetic measurement (for example, measures electric current and/or power consumption, the electric current of measurement power source and/or power attenuation, the measurement work(of pump The residual capacity in rate source etc.), or any combination of them.According to the flow rate of monitoring, such as by comparing the flow rate and one group of threshold Value (for example, determining in demarcation), controller is executable and/or is programmed to execute according to various system requirements to control to be The algorithm or logic of the operation of system.For example, controller is configurable to obtain periodically measured values or from pump horse from pressure transducer Up to acquisition periodic feedback.Pressure below the measurable dressing of pressure transducer.Controller can for example by determining barometric gradient, pressure The rate of change and/or Decay Rate of power is determining flow rate.For example, normal pressure gradient (for example, ever-increasing barometric gradient) Ever-increasing flow rate can be reflected as (for example, leaking) relevant with threshold value, and controller can be programmed to user refer to Show the state.

In certain embodiments, system can be arranged for processing wound.Dressing can be in wound circumference (for example, in dressing Lower section) substantially sealed or closing space is formed, and pump group part can have and regularly or continuously can measure or monitor The sensor of the stress level in the space.Pump group part or its controller be configurable to by the space (for example, under dressing Stress level just) is controlled in the first negative pressure set point limit and at least between the second negative pressure set point limit.In some enforcements Example in, the first set point limit can be about -70mmHg, from about -60mmHg or with down to about -80mmHg or with On.In certain embodiments, the second set point limit can be about -90mmHg, or from about -80mmHg or with down to big About -100mmHg or more.

In certain embodiments, system is configurable to include " retrying " function and/or logic.Pump group part is configurable to Pressure-reduction level (which may correspond to the pressure-reduction level in wound cavity), the level for comparing monitoring and expectation below monitoring dressing is negative Voltage levels (for example, the first set point, second set point etc.), and when not up to expecting pressure-reduction level in certain time interval in Only or suspend treatment.After stopping or suspending treatment, pump group part is configurable to restart to treat (for example, restart negative pressure Source) and attempt producing the expectation pressure-reduction level below dressing again.Retray function can for example be saved the power of battery and allow wink When and/or non-momentary leakage be solved in the case of no user intervention or allows user repair leak (for example, stretch Dressing, repairing are sealed, check one or more connections, etc.).In certain embodiments, controller is executable and/or is programmed To perform retray function and/or logic.

In certain embodiments, system be configurable to by switch, button etc. provide " start/suspend " function and/or Logic, these switch, buttons etc. on the outside of the shell of pump group part or can by user touch it is any other suitable At position.Beginning/pause function can allow user to stop and/or restart to treat (for example, suspend and/or restart pump). Pump group part is configurable to automatically restart treatment after certain predetermined or variable time-out interval.Pump group part can quilt It is configured to automatically restart treatment when such interval is expired and/or indicates that such interval is expired to user.

In certain embodiments, system is configurable to provide instruction, warning of reflection mode of operation etc. to user.System System may include visual, audible, tactile and other types of indicator and/or alarm, and which is configured to user send close In the signal of various modes of operation.Such state include system switching, standby, time-out, normal operating, dressing problem, leakage, Mistake etc..Indicator and/or alarm may include speaker, display, light source etc., and/or combinations thereof.For example, can lead to Cross start or disable negative pressure source, reduce pressure-reduction level, amount of power for being used by negative pressure source of reduction for being produced by negative pressure source etc. or Combinations thereof is providing instruction.

Fig. 1 shows the embodiment of reduced pressure wound equipment 100, and which includes wound dressing 102 and pump group part 104. In any one apparatus embodiments disclosed herein, as shown in FIG. 1 in embodiment, pump group part can be without pot type pump Component (this represents that pump group part does not have exudate or liquid collection tank).However, any one pump embodiment disclosed herein It is configurable to include or supports tank.In addition, in any one apparatus embodiments disclosed herein, any one pump group part Embodiment all may be mounted to dressing or be supported by dressing or neighbouring dressing.Dressing 102 is can be placed on wound (not shown), is such as existed U.S. Patent application No. 13/092, in 042 in greater detail, the disclosure of which is herein incorporated by reference simultaneously Constitute a part of this disclosure；Then conduit 106 can be connected to dressing 102.Dressing 102 is disclosed herein any other Dressing can with any one material in any one dressing embodiments disclosed in U.S. Patent application No. 13/092,042, Size, part or other details, and such embodiment and its diagram just as constitute a part of this disclosure with quote Mode is incorporated by herein.Conduit 106 or any other conduit disclosed herein can be by polyurethane, PVC, nylon, poly- second Alkene, organosilicon or any other suitable material are formed.

Some embodiments of dressing 102 can have end (for example, the first end of conduit 106 for being configured to reception conduit 106 Portion 106a) port 108, what the port 108 of even now was not required.In certain embodiments, conduit can be otherwise Through dressing 108 and/or below dressing 108, Reduced pressure source is supplied to the space between dressing 102 and wound, so as to Desired pressure reducing horizontal is maintained in the space.Some embodiments of equipment 100 can be configured so that the first end of conduit 106 Portion 106a is pre-attached to port 108.Conduit 106 can be any suitable product, and which is configured in pump group part 104 and dressing The fluid flowing passage at least substantially sealing is provided between 102, so that the decompression provided by pump group part 104 is supplied to dressing 102。

Dressing 102 can be provided as single product, wherein all wound dressing elements (including port 108) are by pre-attached union Into in individual unit.Wound dressing 102 then can be connected to the negative pressure source of such as pump group part 104 via conduit 106.At some But such as EZ CARE (TM) pump in embodiment, although it is not required that, but pump group part 104 can be miniaturization and portable, Larger conventional pumps can also be used for dressing 102.

It should be appreciated that embodiments of the invention generally are suitable for used in local decompression (" TNP ") treatment system.In short It, negative pressure wound therapy is by reducing the formation of tissue edema, promoting blood flow and granulation tissue, and/or removing excessive oozing Go out thing and contribute to closure and the healing of the wound of " being difficult to heal " of many forms, and can reduce bacterial load (and therefore feel Dye risk).Additionally, treatment allows to reduce wound interference, cause faster to heal.TNP treatment systems also can be by removing stream Body simultaneously can help the wound healing by surgical closure by the tissue of the stable juxtaposition at closure of help.TNP Another advantageous applications for the treatment of are found in graft and flap, and wherein removing for excess fluid is important, and is needed So that graft close to tissue guaranteeing tissue activity.

Wound dressing 102 is can be located above pending wound location.Dressing 102 can form basic above wound location The cavity or sealing cover of upper sealing.It should be appreciated that in the full text of present specification, reference is wound.But in this sense, It should be appreciated that term wound will be interpreted broadly and cover open and close wound (wherein skin is torn, cuts or pierces Wear or wherein wound cause contusion), benefit from reduced pressure treatment on the skin of the patient or other places any other surface Or other diseases or defect.Therefore wound is broadly defined as the tissue that can wherein produce or can not produce fluid Any damaged area.The example of such wound include but is not limited to acute wounds, chronic wounds, operative incision and other cut Mouth, subacute and gaping wound, traumatic wound, flap and skin graft, laceration, scratch, contusion, burn, diabetes Property ulcer, pressure ulcers, stoma, surgical wound, wound and venous ulcer etc..In certain embodiments, TNP systems described herein Part may be particularly suitable for oozing out the incisional wounds of a small amount of Wound exudate.

Some embodiments of equipment are designed to operate in the case where exudate tank is not used.Dressing 102 is configurable to With the high film of vapor permeability, to allow unnecessary fluid evaporator, and there can be the super-absorbent material being included in, Safely to absorb Wound exudate.Some embodiments of equipment are designed for being intended for single use treatment can be from seven days to 11 Thrown aside after it substantially maximum use time in environmentally appropriate manner.Pump can be programmed to (for example, exist after desired natural law Seven days are afterwards) automatically stopped treatment, the further operation of pump will be impossible.Some embodiments are designed for longer or anti- Multiple use, and be configurable to support exudate tank.

Equipment 100 may be produced that a variety of models or version, and the wherein size of dressing 100 can change various to adapt to Wound size scope.For example, equipment 100 may be produced that the dressing 102 with following size and wound pad (that is, not shown in Fig. 1 Absorber element).

Approximate dressing size	Approximate wound pad size
		10cm×30cm(4in×11.75in)	5cm×20cm(2in×8in)
15cm×15cm(6in×6in)	10cm×10cm(4in×4in)
		15cm×20cm(6in×8in)	10cm×15cm(4in×6in)
10cm×20cm(4in×8in)	5cm×10cm(2in×4in)
		20cm×20cm(8in×8in)	15cm×15cm(6in×6in)

Some embodiments of covering or dressing can be air stream and the antibacterial that substantially impermeable passes through overlying strata Or other contaminant streams, while can pass through steam transmission.

In some embodiments it may be preferable to be partially or even wholly to fill wound location with wound packing material. The wound packing material be it is optional, but be probably for example compared with gash some wounds needed for.Wound packing material Can be used as the supplement of wound dressing 102.Wound packing material generally may include porous and conformal material, for example, steep Foam (including reticulated foams) and gauze.Preferably, wound packing material is by size design or is configured to coordinate in wound location It is interior, to fill any space soared.Then wound dressing 102 can be placed on the wound of wound location and overlying wound location Above mouth packing material.When using wound packing material, once wound dressing 102 is sealed in wound location, just by TNP Wound location is delivered to by wound dressing 102, by wound packing material from pump.Wound exudate is flowed by the negative pressure with other Body or secretions detach wound location.

In certain embodiments, pipe arrangement 106 can have the adapter 112 being positioned at the second end 106b of pipe arrangement 106. Adapter 112 be configurable to the conduit 114 of the short length stretched out from pump group part 104, and connect with the conduit 114 of the short length The adapter 114a of logical cooperation and the adapter (as described in more detail below) supported by pump case, or otherwise Connection.In certain embodiments, the length of pipe arrangement 114 can be about 14mm (0.55 inch) or from about 0.5 inch to About 5 inches.When laying or being otherwise shelved on pump and adapter 112, the conduit or pipe arrangement 114 of the short length can Reduce the discomfort of patient.Pump group part 104 and pipe arrangement 106 are configured so that into that pipe arrangement 106 can be from pump group part 104 rapidly and easily Remove and can be conducive to or improve dressing or pump and change process (if necessary).Any pump embodiment disclosed herein can It is configured to that there is between pipe arrangement and pump any connecting structure disclosed herein.

In certain embodiments, as in the illustrated embodiment, pump group part 104 can have sufficiently small and portable size, with Just support on the body of the user or in the clothes of user.For example, pump group part 104 can be sized to use medical adhesive Band is otherwise in comfortable position, neighbouring dressing 102 or in dressing 102 or other places are attached to the skin of people.Additionally, Pump group part 104 can be sized to coordinate in the trousers or shirt pocket of people, or can use lashing, store bag or other Suitable device or product tie the body of people.

In certain embodiments, pump group part 104 by one or more battery (for example, two batteries) energy supply and be able to can be weighed about 84 grams are less than 90 grams, including including the weight of battery.In certain embodiments, pump group part 104 can have any desired quantity Battery and can focus on from about 80 grams to about 90 grams or from about 75 grams to about 100 grams or within the above range Any value between.For example, can be by reducing battery size and/or weight (reducing to such as AAA batteries or less) or pump chi Very little and/or weight and reduce the weight and/or size of pump group part 104.

Additionally, some embodiments of pump group part 104 can be sized to about 92.5 cubic centimetre (about 5.6 Cubic inch), or 92.5 cubic centimetres (5.6 cubic inches) or following, or at 75 cubic centimetres or less and 115 cubic centimetres Or more between, or the total measurement (volume) limited by the outer surface of pump between 85 cubic centimetres and 100 cubic centimetres.In addition, pump Component 104 can using the further miniaturization of technology known to persons of ordinary skill in the art to about 40 cubic centimetres, or 40 cubic centimetres or less, or the size between 30 cubic centimetres or less and 60 cubic centimetres or more.Pump Some embodiments of component 104 can be sized to 2 cubic inches or less and 6.5 cubic inches or more it Between, or from about 4 cubic inches to about 6 cubic inches, or any value within the above range between total measurement (volume).

Pump group part 104 may have about 7.2cm × about 6.4cm × about 2.1cm (or 7.2cm × 6.4cm × 2.1cm), or maximum about 8.5cm x about 8.5cm x about 3cm total external dimensions.In addition, pump group part 104 can have Total external dimensions of about 5.5cm × about 4.8cm × about 1.5cm (or 5.5cm × 4.8cm × 1.5cm).As mentioned , the size and weight of pump group part 104 can be optimised, as in presently disclosed embodiment, so as to by user more Cosily dress or carry, so as to provide the mobility of increase.

The range of negative pressure of some embodiments of the present disclosure can be about -80mmHg, or in about -20mmHg and -200mmHg Between.It should be noted that these pressure are for home atmospheric pressure, therefore, -200mmHg actually should be about 560mmHg.In certain embodiments, the pressure limit can be about between -40mmHg and -150mmHg.Alternatively, can be with Using at most -75mmHg, at most -80mmHg or the pressure limit more than -80mmHg.In addition in other embodiments, can make With the pressure limit less than -75mmHg.Alternatively, can be supplied more than about -100mmHg or or even 150mmHg by equipment 100 Pressure limit.With regard to pump group part 104 operation other details in U.S. Patent application No. 13/092, be set forth in 042, And like that full text is simultaneously by reference just as constituting a part of this disclosure for such embodiment, configuration, details and its elaboration Enter herein.

Fig. 2A -2F are the various views of the embodiment of the pump group part 104 illustrated in Fig. 1.Fig. 3 A show wound dressing set The embodiment of part 100, dressing which includes being supported in the first packaging element 150 102 (its can be it is disclosed herein or with Any one in the dressing embodiments that way of reference is incorporated herein), pump group part 104, conduit 140, one or more battery 142 (illustrating two), and one or more sealing strips 148.Fig. 3 B are looking up for the embodiment of the wound dressing external member 100 of Fig. 3 A Axonometric chart.Fig. 3 C are the exploded views of the embodiment of the wound dressing external member 100 of Fig. 3 A.

Reference picture 2A-3C, pump group part 104 can have：Shell 120, which includes the first casing component 120a and second housing Component 120b；Control knob 122 (which alternatively switchs or other similar parts)；Battery cover 124；Adapter 128；And one Individual or multiple lamps, which can be LED.In certain embodiments, pump group part 104 can have more than one button 122, and can have Three or more lamps 132.Lamp 132 is configurable to various operations and/or the malfunction for pointing out user pump group part 104, Including prompting user is normal or correct mode of operation, failure of pump, the power of supply to pump or power failure, the state of battery Or voltage level, detect dressing or the leakage in flow passage, suction blocking, any other like or suitable state or Combinations thereof.

Shell 120 can be configured so that the sterilizing gas of such as ethylene dioxide can be penetrated in shell so that pump group part 104 internal part is exposed to sterilizing gas during normal disinfecting process.Generally, pump will substantially evacuation of air or appoint What sterilizing gas are exposed in the room of its gas so that during sterilizing gas are drawn into pump case 120 and other spaces and pump In room in component 104.For example, some embodiments of pump case 102 can have around the unsealing gap of adapter 128, institute State sterilizing gas and can pass through the gap.In addition, in certain embodiments, the first casing component 120a can be coupled to second housing Component 120b and do not use sealing between the two.

For disinfecting process, in certain embodiments, part to be sterilized can experience following steps, especially with appoint What order is carried out.The room or appearance for being evacuated to about 70mBarA (or between 67mBarA and 80mBarA) can be placed the mean in About 15 minutes and 1 hour are maintained in device and between 15 minutes.Part can be also made to undergo inert diluents, steam pressure or tune Reason, or nitrogen cycle, the pumping cycle that the nitrogen cycle can be immediately other.Oxirane or any other suitable sterilizing gas can be During room or container are introduced under the pressure set-point of about 482mBarA (or from about 467mBarA to about 500mBarA).Part Can about 46 degrees Celsius (or from about 42 degrees Celsius to 49 degrees Celsius), or at most 60 degrees Celsius at a temperature of be exposed to sterilization Gas.Part can be exposed to sterilizing gas up to about 10 minutes (short cycle) or about 1 hour (long period), or from about 9 points Clock to about 11 minutes (short cycle), or from about 59 minutes to about 1 hour (long period), or longer time.Part or room Available nitrogen and/or air douche, and/or and then degasification.

Pump group part 104 can be by 142 energy supply of one or more battery.Battery 142 can be chlorination lithium battery or be adapted to exposure In ethylene dioxide and/or any other suitable battery of other sterilizing gas.Battery 142 may be supported on pump case 120 Outside, to minimize or eliminate the probability of the electric spark when the battery is supported in one or more packaging elements, Electric spark can set off an explosion in the case of there is sterilizing gas or explosive gas during disinfecting process.In addition, many when existing During individual battery 142, battery is separated in being spaced apart or being otherwise in packaging, to prevent during disinfecting process in other words It is any power loss or spark of battery before the use.

Reference picture 3A, battery 142 and one or more sealing strips 148 are can be positioned on below dressing 102 so that removing electricity Dressing 102 must be removed from the first packaging element 150 before pond 142, so as to suggested the part of dressing external member 100 from packaging 150 remove and/or are applied to patient or are assembled into the order adopted by other parts of constitution equipment 100.

In certain embodiments, conduit 140 is can be positioned in packaging 150 so that two ends of conduit 140 all depart from or Otherwise disconnect from other parts of equipment 100, improving the inner surface of conduit 140 to the exposure of sterilizing gas and/or Guarantee that pipe arrangement is completely exposed to sterilizing gas.Two ends of conduit 140 may be supported on and be formed in the first packaging element 150 In recess.

First packaging element 150 can have one or more recesses for the part for being configured to receiving and support equipment 100, bag Include for receiving the recess 190 of pump group part 104, the recess 192 for receiving dressing 102, for receiving one or more to seal The recess 194 of bar 148 and/or conduit 140, the recess 196 for receiving conduit 114 and/or adapter 114a (if present)s, And for the recess 200a and 200b spaced apart of battery 142.Battery interval is opened and can be reduced or eliminated in the disinfectant program phase Between by the risk exploded caused by the potential inflammable property of oxirane.

In certain embodiments, the first packaging element 150 can be by sufficiently rigid and/or firm material or combination of materials system Into battery, pump and/or other parts to be held in place during the process of dressing external member or transport.For example, the first packaging unit Some embodiments of part 150 are configured to the part of such as battery, pump or other parts and provide compression or interference fit, should Cooperation be enough to undergo in about 15G and about between 25G, or between 1G and 40G, or between 1G and 20G, or in 25G and Acceleration between 40G.Some embodiments of first packaging element 150 are configurable to closely keep pump, battery, pipe arrangement (there is pipe arrangement press section or recess) and other parts, it is sufficient to prevent from causing packaging short circuit or melting/abrasion so as to cause bag Dress is damaged or antibacterial invades part movement or misplace, while not weakening user removes such part from packaging when needed Ability.

In addition, as illustrated, the first packaging element 150 can have groove or recess 193, which is sized and configured for Surgeon or user is facilitated to utilize and be unfavorable for that glove handss touch the various parts with removing device 100.Additionally, convex Block or protuberance 195 can be formed in the first packaging element 150, to provide extra support and guarantor to packaging and set components Shield.First packaging element 150 can be made up of any suitable material that can be sterilized, including by Nelipak Custom Pure PETG bluenesss 0.80 Eastman, 6763 medical grade materials of the recoverable that Thermoformed Products are provided. Packaging element 150 can be extruded from EASTAR (TM) Chemical Product EASTAR conjugated polyester resins and hot forming.Example Such as, using vacuum-thermoform and can be pressed on stain kit at high temperature for the raw material of extrusion sheet or film.For first Other suitable materials of packaging element 150 include Merlon, the suitable resins of PVC or any other or plastic material.One In a little embodiments, the first packaging element can by the thickness with 0.8mm (or about 0.8) or 0.8mm or following, or 1.0mm or Below, the thickness or between about 0.7mm and 1.2mm material (include plate, sheet material, film or other) make.

Breathable covering 151 (referred to herein as the second packaging element) can be sealingly positioned at the first packaging Above element 150, to provide antibacterial and contaminant barriers for the content of dressing external member 100.For example, TYVEK (TM), paper Or the platy layer or film of any other suitable material be sealed to the edge portions 153 of the first packaging element 150.Covering 151 can be made up of any suitable material, including TYVEK, its permeable sterilizing gas, but provide to antibacterial and other pollutant Barrier.Covering 151 can be opaque, transparent or translucent.

Covering 151 can be wrapped with first after all dressing set components are all assembled in the first packaging element 150 Dress element 150 hermetically couples.Then, the first packaging element 150, covering 151 and dressing set components can be positioned in close In the impermeable bag of envelope, this bag has TYVEK or the permeable material of other sterilizing gas on the opening being formed in bag Material paster, the part to allow sterilizing gas in bag and to dressing external member carry out disinfection.

Fig. 4 A and Fig. 4 B are the first and second exploded views of the embodiment of the pump group part 104 of Fig. 1, are shown and second housing The detached first casing component 120a of component 120b.Fig. 5 A and Fig. 5 B are first and second views of the first casing component 120a. Fig. 6 A and Fig. 6 B are first and second views of second housing component 120b.Reference picture 4A-6B, some enforcements of pump group part 104 Example can have the battery compartment 220 for supporting or being formed in shell 120.One or more battery contact 222 may be supported on battery compartment In 220.Battery contact 222 can be connected to pump 232 and/or panel 230 by one or more electric wire 224.Pump group part 104 can be Assemble in toilet with reduce pump during assembly be exposed to or the pollution that may collect or biological load risk.

In certain embodiments, pump 232 may include motor, ingress port or adapter 250 and outlet port 252.Pump 232 Can have one of which or multiple valves.For example, the first valve can neighboring entry port 250 be positioned in pump 232.In addition, the Two valves can be positioned in pump 232 adjacent to outlet port 252.Pump 232 can be limited by ingress port 250, by first and second Valve simultaneously leaves the flow channel of outlet port 252.

In certain embodiments, battery contact 222 is also configurable to have polarity protection.For example, similar to neighbouring electricity One or more projections 124d of pond contact 125, the plasticity of one or more the Ju Youed adjacent contacts in battery contact 222 or Other projection (not shown), with prevent battery contact 222 and with it is incorrect orientation insert battery compartment in battery not just The really contact between side.For example, one or more projections can be sized and configured for preventing the negative of standard cylindrical battery Battery contact 222 of the pole side contacts in neighbouring one or more prominences, while the positive pole side contacts electricity of battery as allowing Pond contact 222.Generally, using this configuration, only when battery inserts battery compartment 220 with correct orientation, the usual ability of the battery Contacted with contact 222, so as to provide polarity protection for pump group part 104.Projection will preferably be made from a material that be electrically non-conductive.Replace For ground or additionally, panel 230 is configurable to have polarity protection feature or part.In addition, panel 230 can have one Individual or multiple fuses are providing the protection for overload conditions and surge power condition.

Pump group part 104 can be with the flow manifold 240 and one-way flow connected with the fluid flowing passage in pump group part 104 Valve 246.Style one-way flow valve 246 (also referred to as check-valves) can be diaphragm valve, and which is by organosilicon or any other suitable elasticity Body or flexible material are made, including but not limited to polyurethane, fluorubber, nitrile rubber, neoprene, polytetrafluoroethylene and other are suitable Material.Other suitable valves for style one-way flow valve are for example and are not limited to umbrella valve, globe valve, leaf valve, duckbill valve.One In a little embodiments, the leak rate of style one-way flow valve 246 can be about 0.05mL/ minutes.In certain embodiments, it is unidirectional to flow Dynamic valve 246 can be positioned in pump 232 or replace the one of valve being positioned in pump 232.

Manifold 240 and/or style one-way flow valve 246 can be connected with adapter 128.In certain embodiments, style one-way flow valve 246 may be supported in manifold 240, and manifold 240 can couple the ingress port or adapter on pump 232 substantially sealedly 250 are otherwise supported in shell 120, to be in fluid communication with ingress port or adapter 250.For example, referring to figure 4A and Fig. 4 B, manifold 240 can be assembled with pump 232 so that inlet connector 250 is received within the opening being formed in manifold 240 In 261.Air or other gases can leave pump 232 by outlet port or adapter 252.During sterilizing, pump 232 can be by structure Cause so that sterilizing gas are may penetrate in the inner space or room of pump 232, to guarantee whole pump 232 (inside and outside both) All sterilize.One or more valves (which can be umbrella valve or any other suitable valve) are can be positioned in pump 232.For example but not Be limited to, one or more valves are may be supported in pump 232, one be positioned adjacent in ingress port 250 and outlet port 252 it is every At one.

To realize optimal sterilization, in certain embodiments, sterilizing gas lentamente can be introduced to optimize disappearing by valve Poisonous gas stream simultaneously prevents the pressure from sterilizing gas from completely closing valve.As described above, valve (such as the first and second valves) can quilt It is configured to be leakage to a certain extent, is entered with the internal part to pump 232 so as to allow sterilizing gas stream to be advanced past valve Row sterilization.For example, valve can be allowed by the leakage flow rate of fluid therein (that is, when the valve is in the closed position by the stream of valve Rate) under nominal or typical working pressures (under the nominal operating pressure of fluid i.e. in the catheter) or in nominal or typical sterilization It is the flow rate between 0.1mL/ minutes and 10mL/ minutes or more under pressure.In some configurations, between two valves or The part of the flow channel between valve and check valve can be the part for being most difficult to sterilize of flow path or pump group part 104.

Some embodiments of pump group part can have piezoelectric pump.Some piezoelectric pumps or other pumps disclosed herein can have or It is configurable to have aperture to perform valve function so that when pump rest, may be up to 200mL/ minutes by the flow rate of pump.Cause This, pump flow rate is may be up in about 300mL/ minutes or 320mL/ minutes or some other embodiments wherein, and first and Two valves (which can be aperture) can each have the leak rate of up to about 200mL/ minutes.

Pump 232 can be any suitable type, such as but not limited to rotary membrane pump or other membrane pumps, piezoelectricity Pump, peristaltic pump, piston pump, rotating vane pump, liquid rotary pump, vortex pump, the membrane pump operated by piezoelectric transducer or any other Any combinations of suitable pump or micropump or said pump.Pump 232 can be the ready-made vacuum pump of such as standard, such as Koge Electronics KPV8A-3A pumps.Pump 232 can also be KNF membrane pumps or any suitable KNF pumps.

Some embodiments of pump can gently up to about 10 grams, or between about 6 grams and 15 grams, or within the above range appoint Between what is worth.Pump 232 may have about 500mL/ minutes or in about 300mL/ minutes or following and about 600mL/ minutes or More than between, or between about 400mL/ minutes and about 500mL/ minutes, or any value within the above range between Pump capacity.In certain embodiments, pump group part 104 may include two or more pumps 232.For example, pump group part 104 can have： First pump, which has high flow rate, and is configured to provide the sudden pressure drop in the space between wound covering thing and wound；And Compared with the second pump of low capacity, which is configured to after initial decompression subtracting for the space being maintained between wound covering thing and wound Voltage levels.In certain embodiments, pump flow rate can be about 20 times of leakage alarm flow rate, and the leakage alarm flow rate can set In about 15 ml/mins.

As it was previously stated, adapter 128 can be screw thread coupling (as shown in the figure), which can be received by screw thread and pipe arrangement The screw thread coupling of the cooperation of 106 end connection.Screw thread coupling 128 can be with nonstandard compared to other medical connectors Object staff cun, to prevent medical practitioner's imprudence to be attached to the luer connector (such as from the adapter of intravenous line) of standard The adapter.

Alternatively, not shown, adapter 128 can be standard hose connector (such as nipple adapter), its It is configured to hermetically be received into pipe arrangement thereon so that being individually connected on the end of pipe arrangement 106 can be omitted in Device.

Manifold 240 can have single port 260, and which is configurable to the conduit or adapter for receiving pressure monitor 262.Pressure monitor can be supported by panel 230 and be configurable to monitor the stress level in fluid flowing passage.Pressure Monitor is configurable to protect motor 232 without departing from predetermined threshold pressure.In certain embodiments, pressure monitor can quilt Demarcate to less than 175+/- 50mmHg.In certain embodiments, pressure monitor can be calibrated to less than 235mmHg.Pressure Power monitor is configurable to the power that motor is cut to when pressure reading reaches predetermined value, and is configured to work as press water The power that motor is returned to when dropping to below predetermined value or second predetermined value is put down, second predetermined value can be pre- higher or lower than first Definite value.In addition, pump group part 104 can be programmed to prevent such overvoltage.Pump group part 104 can be configured so that software provides use In the main mechanism for preventing overvoltage, and pressure monitor can provide standby overvoltage protection.

Pump 232 can have one layer of open celled foam or the other materials being wrapped in around the outer surface of pump 232 at least in part, To reduce the noise and vibration that are produced by pump 232.All these parts all may be supported on the first pump case component 120a and second In pump case component 120b, the two components can be fixed together with any suitable securing member 270 (for example, a pair of screws). One or more labels 270 could attach to the outer surface of shell 120.In addition, in certain embodiments, pump 232 can have one Or multiple counterweights, liner, foam (such as viscoelastic foam), plastics (for example, ABS, polyurethane, carbamate or other), Or other pad, panel, sheet material or sections, which is supported or be positioned adjacent to by pump 232 one or more outer surfaces of pump.One A little embodiments can be with based on quality or conformal damping material.This base part or material (not shown) can damp what is produced by pump Vibration and/or noise attenuation.

For example, one or more counterweights (being made up of steel, metal or any other suitable material) can be supported or are attached To pump 232 or the outer surface of any other pump embodiment disclosed herein.Steel counterweight can great about 1.8 grams, 3.8 grams, or 5.8 Gram, or between 1 gram and 10 grams or more, or between 1.5 grams and 6 grams.Two or more counterweights can be supported or are attached To pump 232 or the outer surface of any other pump embodiment disclosed herein.Can by each great about 1.8 grams, 3.8 grams, or 5.8 Gram, or between 1 gram and 10 grams or more, or two steel between 1.5 grams and 6 grams with the outer surface for being reattached on pump 232. Each in two plates is can be positioned in the opposite sides of motor 232 or other positions.In certain embodiments, can will be each heavy About 1.8 grams, 3.8 grams, or 5.8 grams, or between 1 gram and 10 grams or more, or four steel between 1.5 grams and 6 grams match somebody with somebody It is reattached on the outer surface of pump 232.It is each in two opposite sides of motor 232 that plate may be disposed so that two plates are positioned at Individual upper or other positions.In certain embodiments, counterweight may be positioned to three or more sides of neighbouring pump 232, including example As and be not limited to the side surface and top surface of pump 232.

Reference picture 4A, battery cover 124 can have breech lock or tab member 124a, its be configurable to on shell 120 Mating feature engagement preventing battery cover 124 from absent-mindedly being opened when in the closed position.In addition, can be in battery cover Guider or projection 124b are formed on 124 to be conducive to readily opening and close battery cover 124.The engageable shapes of guider 124b Into cooperation guider or groove 120c in shell 120.Battery cover 124 is configurable to have grasping surface, for list Individual finger is used.Such as but not limited to, multiple depressions 124c can be formed on the surface of battery cover 124, to strengthen user Grasping between finger or other objects and battery cover 124, to be conducive to the opening and closing of battery cover 124.

Reference picture 4B, battery cover 124 can support one or more battery contact or terminal 125 thereon, and which is configured to Connection is provided between two batteries.Battery cover 124 also can support one or more projections 124d of adjacent cells contact 125. One or more projections 124d can be sized and configured for preventing the negative pole side contacts of standard cylindrical battery neighbouring one Battery contact 125 at individual or multiple projections 124d, while the positive pole side contacts battery contact 125 of battery as allowing.Profit This configuration is used, only when battery inserts battery compartment 220 with correct orientation, the battery generally could be contacted with contact 125, So as to provide polarity protection for pump group part 104.

Reference picture 4A and Fig. 4 B, shell 120 can have one or more inserted sheets 121 and depression or groove 123, depression or logical Groove 123 is configured to receive inserted sheet 121 to improve the connection between two components 120a, 120b of shell.Inserted sheet 121 and depression The edge of shell 120 preferably can be kept together by 123, with two components for improving the intensity of shell 120 and make in shell Connection between 120a, 120b is tightr.Panel 230 can utilize similar feature to be assembled into shell 12.

As in U.S. Patent application No. 13/092,042, (the disclosure of which is as in fully elaboration herein with reference side Formula is incorporated herein) described in, lower surface of any one of 102 embodiment of wound dressing disclosed herein can have optional Wound-contacting layer.Any one in dressing embodiments disclosed herein is may be produced that without wound-contacting layer.Wound contact Layer can be layer of polyurethane or polyethylene layer or other flexible layers, and which can for example pass through hot pin technique, laser ablation process, surpass Sound wave technique or be made in some other manner it is porous or perforation, or be otherwise made for liquid permeable and Gas.Perforation can allow fluid and/or gas to flow through the layer.Wound-contacting layer can help to prevent from organizing interior life to apply to wound In the other materials of material.

Boring a hole, it is sufficiently small to meet this requirement to be dimensioned to, but still allows fluid from.For example, it is configured to have The slit of the size range from 0.025mm to 1.2mm or the perforation in hole are considered as sufficiently small, to contribute to preventing from organizing interior life to arrive In wound dressing, while allowing Wound exudate to flow in dressing.Wound-contacting layer contributes to being maintained at whole wound dressing Together and contribute to forming the gas-tight seal around absorption pad, to keep negative pressure in wound.Wound-contacting layer is also functioned as can The bottom of choosing and the carrier of top adhesive phase (not shown).For example, bottom can be set on the downside surface 101 of wound dressing Contact adhesive, while top pressure sensitive adhesive layer can be arranged on the upper surface 103 of wound-contacting layer.Contact adhesive can be with It is organosilicon, heat fusing thing, aqueous colloidal or acrylic adhesives or binding agent as other, and both sides can be formed at It is upper or alternatively on the selected side in the side of wound-contacting layer or both sides all do not have the contact adhesive.When using bottom During pressure sensitive adhesive layer, this contributes to wound dressing is adhered to the skin around wound location.

As it was previously stated, any dressing used in dressing external member that is disclosed herein or being herein incorporated by reference Embodiment can all have bottom (for example, the Wound contact) surface of adhesive coverage.In certain embodiments, as it was previously stated, viscous Mixture can be silicone adhesive, including such as polysiloxanes or polysiloxane or the pressure-sensitive organosilicon of other polymer-types Binding agent.For example, can be using polydimethylsiloxane etc..Adhesive formula can be the siloxanes (alkyl with alkyl side chain Pendant siloxane) mixture, which can spread and be cast into two parts mixture with catalyst so that final Polymerization procedure occurs after casting or distribution.In certain embodiments, dressing layer can be with the silicone adhesive without perforation Coating (nominal coating weight 130gsm) and it is coated in the opposite sides of EU30 polyurethane light-transmissive film (27 to 37gsm) of extrusion Abundant distribution acrylic adhesive (27 to 37gsm).The vapor permeability of some embodiments of such arrangement can In about 367gm^-2/ 24 hours to about 405gm^-2Between/24 hours, or 382gm^-2The average vapor of/24 hours oozes Saturating rate.

Be adapted to dressing embodiments disclosed herein silicone adhesive layer some embodiments or arrangement can with About 350gm^-2/ 24 hours and about 410gm^-2Vapor transmission rate between/24 hours.Suitably, it is adapted to institute herein public The average vapor permeability of some embodiments or arrangement of the silicone adhesive layer of the dressing embodiments opened can be about 380gm^-2/ 24 hours.Some Ju Youed coatings in dressing embodiments disclosed herein Wacker silres thereon 45 contact adhesives of PSA.

In addition, in dressing embodiments disclosed herein any one can have be attached to dressing in or be coated on dressing Antimicrobial or material on one or more surfaces.Such as but not limited to, any dressing embodiments disclosed herein Wound-contacting layer can have nanocrystalline silver-colored agent in or on which, silver salt, mantoquita or gold salt (such as but not limited to 2008 5 11/922,894 (entitled " the ANTIMICROBIAL BIGUANIDE METAL of U.S. Patent application No. that the moon 21 was submitted to Those disclosed in COMPLEXES ", this application are herein incorporated by reference just as constituting a part of this disclosure In), PHMB, chlorhexidine (chlorohexadine), hydrogen peroxide, hypochlorite or other bleachs.Additionally, this The absorbed layer of any dressing embodiments disclosed in text can have silver sulfadiazin (silver in or on which Sulphur diazine) or material mentioned before this or activating agent in any one.These materials can be separately or together Use.These materials can eliminate the microorganism in microorganism and absorption base in wound respectively.As a further alternative, Other active components, the analgesic or rehabilitation agent of such as such as ibuprofen can be combined in dressing.In addition, can combine in dressing The agent or the agent of inhibitory enzyme of the raising cytoactive of such as somatomedin, such as such as matrix metallo-proteinase inhibitor, metal The tissue depressant (TIMPS) of protease or zinc chelating agen.The abnormal smells from the patient capture element of activated carbon, cyclodextrin, zeolite etc. In also being included in the other parts or composition of absorbed layer or dressing or on filter layer.

Porous material layer is can be located on wound-contacting layer.The porous layer or transport layer allow the stream for including liquids and gases Body is transferred in the upper strata of wound dressing away from wound location.Especially, transport layer can ensure that the air groove that can keep open To connect the negative pressure above wound area, or even when absorbed layer has absorbed the exudate of significant quantity.The layer should be as described above To keep opening under the typical pressure that be applied in, so that whole wound location undergoes in a balanced way during negative pressure wound therapy Negative pressure.This layer can be formed by the material with three dimensional structure.For example, the space fabric of knitting or braiding can be used (for example, 7970 weft-knitted polyester of Baltex) or non-woven fabrics.Other materials can be adopted, the example of such material is in U.S. Patent application No. It is described in 13/092,042, this application is herein incorporated by reference and constitutes a part of this disclosure.

In certain embodiments, transport layer can have 3D polyester spacer fabric layers.The layer can have top layer (that is, In use away from the layer of wound bed), bottom (that is, in use near wound bed place layer) and be formed as folder Third layer between the two layers, top layer are 84/144 veining polyester, and bottom can be the flat polyester of 100 daniers, the Three layers is the region limited by monfil such as knitting polyester fiber viscose glue, celluloses.Can using other suitable materials and The fiber of other linear mass densities.

This species diversity between silk quantity in layer spaced apart contributes to controlling the dampness for crossing transport layer flowing.Especially Ground, by making the silk quantity in top layer bigger, that is to say, that top layer is by the yarn system with yarn more multifibres used by than bottom Into, liquid along top layer compare bottom be intended to it is more by wicking.In use, the difference is intended to liquid is inhaled from wound bed Walk and suck in the central area of dressing, in central area, absorbed layer help by liquid latch or its own continue forward towards Coating wicking liquid, in coating, which can be evaporated.

Preferably, transport layer is crossed in order to improve（That is, pushing up between wall and bottom wall perpendicular to being formed in Groove region）Liquid flowing, with Dry Cleanerss (such as but not limited to perchloroethylene）To process 3D fabrics to help remove it The front any manufacture product for using, such as mineral oil, fat and/or wax, the manufacture product may affect the hydrophilic of transport layer Ability.In certain embodiments, additional manufacturing step is can perform afterwards, wherein, (such as but not limited to can be from hydrophilizing agent The Feran Ice 30g/l that Rudolph Group are obtained) middle washing 3D space fabrics.The process steps are assisted in ensuring that on material Surface tension be so small that the liquid of such as water just can enter fabric in the knitting fabrics of contact 3D at which.This also helps Control the flowing of the liquid insult composition of any exudate.

Equally, such as in 042 in greater detail, can arrange on transport layer in U.S. Patent application No. 13/092 Layers of absorbent material.Absorbing material can be foam or nonwoven naturally occurring or synthetic material and can optionally include or just It is super-absorbent material, the absorbing material is defined for the fluid (liquid for especially removing from wound location）Storage simultaneously And those fluids are aspirated towards coating.The material of absorbed layer can prevent liquid of the collection in wound dressing with sloshing mode stream It is dynamic.Absorbed layer can also help be distributed fluid in whole layer by core sucting action, so that fluid is sucked out from wound location And it is stored in whole absorbed layer.This contributes to the caking aggregation in the region for prevent absorbed layer.The capacity of absorbing material Must be enough to manage the exudate flow rate of wound when negative pressure is applied.As absorbed layer experiences negative pressure in use, therefore absorb The material of layer is selected as absorbing liquid in this case.There are many materials being capable of absorbing liquid when under the negative pressure Body, such as super-absorbent material.Absorbed layer can be by ALLEVYN foams, Freudenberg 114-224-4 and/or Chem- Posite 11C-450 or any other suitable materials are made.

In certain embodiments, absorbed layer can be non woven fibre cellulose fiber layer, and which has scattered drying everywhere The super-absorbent material of particle shape formula.The use of cellulose fibre introduces quick wicking elements, and its help is rapidly and evenly It is distributed the liquid drawn by dressing.The juxtaposition of many strand fibers causes the strong capillarity in fiber mat, and this contributes to distribution Liquid.So, super-absorbent material is efficiently supplied liquid.And, all regions of absorbed layer are provided liquid.

Core sucting action also helps make liquid contact with upper caldding layer to help to increase that the evaporation rate of dressing.When exudate subtracts During slow or stopping, core sucting action also helps liquid is conveyed downwardly toward wound bed.The course of conveying is helped transport layer and bottom Wound bed region keeps wet, and this contributes to preventing the crust (this can cause blocking) in dressing and contributing to remaining right The optimum environment for wound healing.

In certain embodiments, absorbed layer can be gas woven material.Optionally can be helped using heat-fusible fiber The structure of pad is remained to together.It should be appreciated that instead of using superabsorbent particles or in addition to such use, can basis Some embodiments of the present invention are using superabsorbent fibers.The example of suitable material is can be from the Emerging in the U.S. The products C hem-Posite 11C that technologies Inc (ETi) are obtained.

Optionally, absorbed layer may include synthesizing stable fiber and/or bi-component stable fibers and/or natural stabilisation fiber And/or superabsorbent fibers.Fiber in absorbed layer can be combined by latex or thermal or hydrogen combination or any combination technology Combination or other mechanism of ammonium fixation and be secured together.In certain embodiments, absorbed layer is by operating into superabsorbent particles The fiber being locked in absorbed layer is formed.This assist in ensuring that superabsorbent particles will not move to absorbed layer outside and towards following Wound bed is moved.This is particularly useful, because when negative pressure is applied with, absorption pad is intended to subside downwards and the action will Superabsorbent particles material is promoted along towards the direction of wound bed, if the superabsorbent particles material does not have absorbed layer If fibre structure is latched.

Absorbed layer may include multifilament layer.Preferably, fiber is strand and by cellulose, polyester, viscose rayon etc. Make.Preferably, it is dried absorbing particles to be distributed in the whole absorbed layer for being ready to use.In certain embodiments, absorb Layer includes cellulose fibre pad and multiple superabsorbent particles.In an additional embodiment, the cellulose that absorbed layer is randomly oriented The non-woven layer of fiber.

Superabsorbent particles/fiber can be that such as sodium polyacrylate or carboxymethyl cellulose etc. or can absorb is multiple times than Any material of the liquid of its own weight.In certain embodiments, the material absorbable is five times in the 0.9% of its own weight W/W normal saline etc..In certain embodiments, 0.9% W/W normal saline of 15 times of its own weight of material absorbable Deng.In certain embodiments, the material can absorb 0.9% W/W normal saline of 20 times of its own weight etc..Preferably, The material can absorb 0.9% W/W normal saline of 30 times of its own weight etc..Absorbed layer can have be positioned at suction One or more through holes under port.

Dressing 102 can be with the gas impermeable extended on the width of wound dressing but vapor is permeable covers Cap rock.Coating may, for example, be the polyurethane film (for example, Elastollan SP9109) with contact adhesive on side Or any other suitable material, and be substantially impermeable gas, so as to substantially sealed envelope is formed above wound Cover.So, effective room is defined between coating and wound location, can set up negative pressure at the room.Coating can enclose For example wound-contacting layer is sealed to via binding agent or solder technology in the borderline region of dressing periphery, so that it is guaranteed that not being free Gas is sucked through borderline region.Coating can be protected wound not by outside germ contamination (bacterial barriers) and allow to feel sorrow for oneself The liquid of mouth exudate is transmitted through the layer and evaporates from film outer surface.Coating can have polyurethane film and be dispersed in the film On pattern of adhesive.Polyurethane film be vapor it is permeable and can by during moistening with increase water transfer rate material Make.

Aperture can be set in coverlay, to allow for negative pressure to be applied to dressing 102.As mentioned, implement at some In example, suction ports 108 can be sealed to the top of the coverlay on aperture and can connect negative pressure by aperture.Can use The port is adhered to by the binding agent of such as acrylic resin, cyanoacrylate, epoxy resin, UV solidifications or hotmelt Be sealed to coverlay.Port 108 can be formed by flexible polymer, such as poly- with the hardness that Durometer A hardness level is 30 to 90 Ethylene, polrvinyl chloride, silicone or polyurethane.

Dressing 102 can have the filter element of impermeable liquid but gas-permeable.Filter element may act as liquid barrier with And odor barriers, substantially to prevent or suppress liquid to overflow from wound dressing.Filter element also is used as bacterial barriers.One In a little embodiments, the hole size of filter element can be about 0.2 μm.For the suitable material bag of the filtering material of filter element Include PTFE, PALL the Versapore 200R and Donaldson of 0.2 micron of Gore extension from MMT scopes TX6628.Therefore filter element allows gas to enough discharge by aperture.However, liquid, granule and pathogenic bacteria are comprised in dressing. It is disclosed in U.S. Patent application No. 13/092,042 and is herein incorporated by reference with regard to other details of filter In.

Wound dressing 102 and production and preparation method thereof also is included in following patent and patent application as described herein Described in feature, configuration and material, every part of document is all incorporated by reference herein in its entirety, just as disclosed in constructions cost It is a part of the same：United States Patent (USP) No. 7,524,315,7,708,724 and 7,909,805；U.S. Patent Application Publication No. 2005/0261642、2007/0167926、2009/0012483、2009/0254054、2010/0160879、2010/ 0160880、2010/0174251、2010/0274207、2010/0298793、2011/0009838、2011/0028918、 2011/0054421 and 2011/0054423；And it is filed in the U.S. Patent application No. 12/941 on November 8th, 2010, 390th, it is filed in the U.S. Patent application No. 29/389,782 on April 15th, 2011, and is filed on April 15th, 2011 U.S. Patent application No. 29/389,783.From the patents and patent applicationss that these are incorporated by reference, for the disclosure Described in the feature of those similar parts, configuration, material and manufacture or using method can be substituted, added or be implemented into this In the embodiment of application.

In operation, wound dressing 102 is sealed in wound location, so as to form wound cavity.Pump group part 104 will be negative Potential source provides dressing 102.Wound location of the fluid from below wound-contacting layer is sucked towards aperture by wound dressing.Fluid Moved towards aperture by transport layer.When fluid is drawn through transport layer, Wound exudate is absorbed in absorbed layer.

The general shape of wound dressing can be square, oval, rectangle or other shapes.Dressing can have fillet area Domain.It should be appreciated that the wound dressing of other embodiments of the invention can be different shapes（Such as square, circle Or it is oval）Dressing etc..

The size and type of the wound being used for can be selected by the desired size of wound dressing 102 according to it.In some realities Apply in example, the size of wound dressing 102 can be in 10 to 25cm between 20 and 40cm and in its short axle on its major axis Between.For example, dressing can be sized to about 10 × 20cm as described above, 10 × 30cm, 10 × 40cm, 15 × 20cm and 15×30cm。

In certain embodiments, wound dressing 102 can be square dressing, and the size of its side is between 15 and 25cm (for example, 15 × 15cm, 20 × 20cm and 25 × 25cm).Absorbed layer compare whole dressing can have less area, and The length and width of absorbed layer about 3 to 10cm short than the length and width of whole dressing 102 in some embodiments, more preferably Short about 5cm.In some rectangular embodiments, absorbed layer can be between about 10 and 35cm and in its short axle on its major axis Can be between 5 and 10cm.For example, absorbed layer can be sized to 5.6 × 15cm or 5 × 10cm (for applying for 10 × 20cm Material), 5.6 × 25cm or 5 × 20cm (for the dressing of 10 × 30cm), 5.6 × 35cm or 5 × 30cm be (for 10 × 40cm's Dressing), 10 × 15cm (for the dressing of 15 × 20cm), and 10 × 25cm (for the dressing of 15 × 30cm).At some just In square embodiment, absorbed layer can have length between 10 and 20cm (for example, the dressing for 15 × 15cm be 10 × 10cm, the dressing for 20 × 20cm be 15 × 15cm, or the dressing for 25 × 25cm be 20 × 20cm) side.Transmission Layer compare absorbed layer can have less size, and in certain embodiments the length and width of transport layer than absorbed layer Short about 0.5 to the 2cm of length and width, more preferably short about 1cm.In some rectangular embodiments, transport layer can on its major axis Can be between 3 and 5cm between 9 and 34cm and in its short axle.For example, transport layer can be sized to 4.6 × 14cm Or 4 × 9cm (for the dressing of 10 × 20cm), 4.6 × 24cm or 4 × 19cm (for the dressing of 10 × 30cm), 4.6 × 34cm Or 4 × 29cm (for the dressing of 10 × 40cm), 9 × 14cm (for the dressing of 15 × 20cm), and 9 × 24cm (for 15 The dressing of × 30cm).In some square implementations, transport layer can have length between 9 and 19cm (for example, for 15 The dressing of × 15cm be 9 × 9cm, the dressing for 20 × 20cm be 14 × 14cm, or the dressing for 25 × 25cm be 19 × Side 19cm).

Dressing can be included in the antimicrobial (such as nanocrystalline silver-colored agent) on wound-contacting layer and/or in absorbed layer Silver sulfadiazin.These materials can be used separately or together.These materials kill microorganism and suction in wound respectively Receive the microorganism in substrate.As a further alternative, it may include other active components, such as analgesic of such as ibuprofen. It is also possible to use the agent or the agent of inhibitory enzyme of the raising cytoactive of such as somatomedin, such as matrix metallo-proteinase inhibitor, The tissue depressant (TIMPS) of such as metalloproteases or zinc chelating agen.As a further alternative, such as activated carbon, ring-type The abnormal smells from the patient capture element of dextrin, zeolite etc. is may include in absorbed layer or as another layer on filter layer.

Although having been described for that wherein transport layer is formed as 3D knitted layers (such as the two-layer being spaced apart by layer of filaments) so far Some embodiments of the present invention, it is to be understood that, some embodiments of the present invention are not limited to using such material.In some realities Apply in example, as the alternative form of such 3D woven materials, one or more layers of various materials can be used.In every kind of situation In, embodiments in accordance with the present invention, when the side for being positioned adjacent to wound in use away from dressing is moved, are passed by each layer The opening that defeated layer is provided is more and more wider.In certain embodiments, transport layer can be provided by multilamellar open celled foam.In some embodiments In, the foam is reticular opening foam.The foam can be hydrophilic or being capable of wicking water-based fluid.Hole in each layer Size is selected such that in use near in the froth bed of wound side hole has minimum size.If only using another One froth bed, then it include the hole size of the hole size more than ground floor.This helps avoid solid particle entrapment in lower floor In, so as to contribute to lower floor being kept in open configuration, air is transmitted therefore, it is possible to run through dressing in wherein lower floor.In some realities Apply in example, it may include two, three, four or more froth beds.Froth bed can for example by selecting with big hole size The foam and then foam is repeatedly immersed with degree less and less will block in the material in the hole and one landform Into；Or alternatively, different types of bubble of the lamination in layered arrangement can be passed through by the transport layer that multiple froth beds are formed Foam or by by these froth beds in position in a known way providing.

Fig. 7 A-7D are illustrated for processing the purposes of the embodiment of the TNP wound treatment systems of the wound location with patient. Fig. 7 A show wound location W for being cleaned and being prepared to be processed.Here, the healthy skin around wound location W is preferred Ground is cleaned, and is removed or wiped unnecessary hair off.If desired, it is also possible to which sterile saline solution irrigates position W.Appoint Selection of land, the skin that Derma-Guard can be applied to around wound location W.If desired, can be by the wound of such as foam or gauze Mouth packing material is placed in wound location W.If wound location W is deeper wound, this is probably preferred.

After the skin around wound location W is ready for, can from the first packaging element 150 remove covering 151 with The path of part is provided.Dressing 102 can be removed from packaging 150 and be positioned as shown in fig.7b and be placed on wound portion On the W of position.Wound dressing 102 may be arranged such that the wound-contacting layer of dressing 102 is covered and/or contacts wound location W.At some In embodiment, adhesive phase can be set on the lower surface of wound-contacting layer, the adhesive phase in some cases can be optional Releasing layer protection, the releasing layer removed before wound dressing 102 is placed in wound location W.Dressing 102 can be positioned Into causing remainder of the port 108 relative to dressing 102 to be in raised position, to avoid fluid from being gathered in around port 108. In certain embodiments, dressing 102 is positioned such that the not direct overlying wound in port 108, but flushes with wound or be in At higher point.In order to assist in ensuring that enough sealings of TNP, the edge of dressing 102 can be flattened, to avoid wrinkle or folding. Dressing and the binding agent being formed thereon can be configured so that dressing can be subsequently lifted skin or wound and reposition to remove folding Wrinkle and folding, or only dressing is repositioned on wound, or for other reasons, and do not sacrifice the performance of binding agent. Pipe arrangement 106 can be connected to dressing 102 before or after dressing 102 is placed on wound.

Then, pump group part 104 can be removed and connected to pipe arrangement 106 from packaging 150, as seen in figure 7 c.Can be attached by pump Battery 142 is removed and is arranged in pump group part 104 from packaging 150 before or after being connected to conduit 106.Pump group part 104 can quilt It is configured to for negative pressure to be applied to wound location via dressing 102 and generally by pipe arrangement or conduit 106.In some embodiments In, adapter can be used to for conduit 106 to engage dressing 102 and pump group part 104.When negative pressure is applied with pump group part 104, due to Some or all in air below dressing 102 are evacuated, and dressing 102 may partly subside in certain embodiments and be in Existing shrinkage outward appearance.In certain embodiments, pump group part 104 is configurable to detect whether that any leakage is present in dressing 102 In, such as the seam between the skin around dressing 102 and wound location W.Once it was found that leakage, is just preferably continuing Such leakage is repaired before process.Can pass through to reposition dressing 102, the fold eliminated in dressing or fold or by dressing Apply fixed strip 148 around 102 periphery and repair the leakage.

Fig. 7 D are gone to, as mentioned, fixed strip 148 is attached around the periphery edge of dressing 102 or other places.So Fixed strip 148 be probably favourable in some cases, to provide extra close to the patient skin around wound location W Envelope.For example, when patient activity is frequent, sealing or fixed strip 148 can provide extra sealing.In some cases, it is fixed Bar 148 can be used before pump group part 104 is started, particularly when dressing 102 is set to the region that is difficult to touch or into wheel When on wide region.In certain embodiments, dressing external member 100 can be provided with up to five sealing strips.

The process of wound location W is preferably continued with, till wound has reached desired healing level.At some In embodiment, it may be desirable to the more change dressings 102 after certain time period passs or when dressing is full of wound fluid. During such replacing, pump group part 104 can be by retain, and only more change dressings 102.

Fig. 8 A-20H are the top perspective view of the embodiment of packaging element, face upwarding stereogram respectively, plan view from above, look up Plane graph, front view, rearview, the first side view and the second side view, the packaging element can be used for wound disclosed herein Any one in the embodiment of applicator device, including various various sizes of wound dressing equipment.It is illustrating in Fig. 8 A-20H or Any one embodiment of packaging element disclosed in other places can all have in this application includes the first packaging element discussed above It is arbitrary in 150 same characteristic features of any one in interior other packaging elements disclosed herein, material or other details It is individual.

Packaging element 300 shown in Fig. 8 A-8H be configured to support the dressing with about 10cm × 20cm sizes and/ Or one or more in other parts of any TNP treatments external member disclosed herein.Packaging element shown in Fig. 9 A-9H 310 are configured to support the dressing with about 10cm × 20cm sizes and/or any TNP disclosed herein to treat external member One or more in other parts.Packaging element 320 shown in Figure 10 A-10H be configured to support with about 10cm × One or more in other parts of the dressing of 30cm sizes and/or any TNP treatments external member disclosed herein.Figure 11 A- Packaging element 330 shown in 11H is configured to support the dressing with about 10cm × 30cm sizes and/or disclosed herein One or more in other parts of any TNP treatments external member.Packaging element 300 shown in Figure 12 A-12H is configured to prop up In other parts of dressing of the support with about 10cm × 40cm sizes and/or any TNP treatments external member disclosed herein One or more.Packaging element 350 shown in Figure 13 A-13H is configured to support the dressing with about 10cm × 40cm sizes And/or one or more in other parts of any TNP treatments external member disclosed herein.Pack shown in Figure 14 A-14H Element 360 is configured to support the dressing with about 15cm × 15cm sizes and/or any TNP treatments set disclosed herein One or more in other parts of part.Packaging element 365 shown in Figure 14 I-14P is configured to support with about 15cm One or more in other parts of the dressing of × 15cm sizes and/or any TNP treatments external member disclosed herein.

Packaging element 370 shown in Figure 15 A-15H be configured to support the dressing with about 15cm × 20cm sizes and/ Or one or more in other parts of any TNP treatments external member disclosed herein.Packaging element shown in Figure 16 A-16H 380 are configured to support the dressing with about 15cm × 20cm sizes and/or any TNP disclosed herein to treat external member One or more in other parts.Packaging element 390 shown in Figure 17 A-17H be configured to support with about 20cm × One or more in other parts of the dressing of 20cm sizes and/or any TNP treatments external member disclosed herein.Figure 17 I- Packaging element 395 shown in 17P is configured to support the dressing with about 20cm × 20cm sizes and/or disclosed herein One or more in other parts of any TNP treatments external member.Packaging element 400 shown in Figure 18 A-18H is configured to prop up In other parts of dressing of the support with about 15cm × 30cm sizes and/or any TNP treatments external member disclosed herein One or more.Packaging element 405 shown in Figure 18 I-18P is configured to support the dressing with about 15cm × 30cm sizes And/or one or more in other parts of any TNP treatments external member disclosed herein.Pack shown in Figure 19 A-19H Element 410 is configured to support the dressing with about 25cm × 25cm sizes and/or any TNP treatments set disclosed herein One or more in other parts of part.Packaging element 420 shown in Figure 20 A-20H is configured to support with about 25cm One or more in other parts of the dressing of × 25cm sizes and/or any TNP treatments external member disclosed herein.

Figure 21 illustrates the pump group part 1000 according to some embodiments.In the embodiment of pump group part disclosed herein 1000 Any one can have be herein incorporated by reference or any other pump group part embodiment disclosed herein (include it is mentioned above The embodiment of pump group part 104) same or similar part, feature, material, size, any one in configuration and other details. Preferably, pump group part 1000 can be miniaturization and portable, but can also use larger Conventional portable or non-portable (example Such as, wall suction) pump.Pump group part 1000 may include switch or button 1002, on the outside of the shell for being shown located at pump group part Beginning/pause button.As explained below, button 1002 is configurable to stop, suspending and/or restart treatment.Though Button 1002 is so shown as, but other types of switch or button, such as touch pad, touch screen, keypad etc. can be included.

Pump group part may also include adapter 1050 (for connecting conduit, for example, conduit 106), and three LED indicators 1062nd, 1064 and 1066.As illustrated, LED indicator 1062 (for example, OK indicators) is just being configurable to instruction system Often/abnormal operation.For example, movable (for example, lighting) indicator 1062 can represent normal operating.1064 (example of LED indicator Such as, dressing indicator) leakage that is configurable in instruction system.For example, movable (for example, lighting) indicator 1064 can Represent leakage.LED indicator 1066 (for example, battery indicator) is configurable to the residue of indicated horsepower source (for example, battery) Capacity or life-span.For example, movable (for example, lighting) indicator 1066 can represent low capacity.In certain embodiments, indicate Device 1062,1064 and 1066 can have different colors, (for example, two indicators can share identical to two kinds of different colors Color), or identical color.Although pump group part preferably includes three LED indicators and beginning/pause button, alternatively Can be using other configurations, the position of indicator and type, alarm and switch.In certain embodiments, pump group part 1000 can be wrapped Visual, audible, tactile and other types of indicator or alarm are included, and which is configured to various modes of operation be sent to user Signal.Such state includes system switching, standby, time-out, normal operating, dressing problem, leakage, mistake etc..Indicator May include speaker, display, light source etc., and/or combinations thereof.

Figure 22 illustrates the sectional view of the inside for showing the pump group part 1000 according to some embodiments.As illustrated, shell 1020 can encapsulate pump group part.Style one-way flow valve 1030 is configurable to keep pressure-reduction level (for example, to prevent when negative pressure source inertia Stopping leak leaks) and prevent from wound the fluid for suctioning out or removing and/or exudate to enter pump group part via adapter 1050.Such as The panel 1040 of printed circuit-board assembly (PCBA) is configurable to mechanically support and electrically connects described below each Plant electrical/electronic components.PCBA can be one side or two-sided.The negative pressure source 1090 of such as pump can suction out fluid from wound And/or exudate.In any one embodiment disclosed herein, negative pressure source 1090 can with it is disclosed herein other bear Any one in same parts, feature, defect or other details of any one of potential source embodiment, including being not limited to above disclosure Pump 232.Various pumps can be used for negative pressure source, including peristaltic pump, piston pump, rotating vane pump, liquid rotary pump, vortex pump, membrane pump, Piezoelectric pump (membrane pump for for example, being operated by piezoelectric transducer) etc., or combinations thereof.Although pump group part preferably includes micro- Type, low noise, low-power pump, but it is alternatively used any suitable pump.(for example, pump group part 1000 includes indicator 1060 LED), for the pressure transducer 1070 of the pressure (for example, the pressure below dressing) in monitoring system, and be configured to provide To the battery cover 1080 of the path of battery compartment 1100.Although pump group part is preferably by the disposable alkaline cell (example of two standards Such as, 2 AA batteries) energy supply, but can alternatively use any kind of power source, including rechargeable battery and external power.

Figure 23 shows the system schematic of the pump group part 1000 according to some embodiments.Pump group part include button 1002, Panel 1040 and indicator 1060.Pump group part 1000 can be by 1130 energy supply of battery unit.Pump group part also includes pump 1090 (for example By the membrane pump of 1092 energy supply of electro-motor) and pressure transducer 1070.Entrance 1120 is configurable to pump group part 1000 Such as dressing is connected to via conduit.Entrance 1120 may be connected to check valve 1030, and check valve 1030 is configurable to work as negative pressure source Pressure-reduction level is assisted in keeping during inertia, leakage is avoided, and prevents from wound the fluid for suctioning out or removing and/or exudate to enter Enter pump group part 1000.Pump 1090 is also connected to outlet 1110.In certain embodiments, outlet 1110 is configurable to air It is discharged into air.In certain embodiments, filter (not shown) is could be sandwiched between outlet and air.Filter can be antibacterial Filter, adour filter etc., or any combination of them.

Figure 24 illustrates the schematic diagram of the electric component of the pump group part 1000 according to some embodiments.Module 1140 can be control Making sheet (for example, PCBA), which may include input/output (I/O) module 1150, controller 1160 and memorizer 1170.At some In embodiment, module 1140 may include additional electrical/electronic components, for example one or more fuses.Controller 1160 can Being microcontroller, processor, microprocessor etc., or any combination of them.For example, controller 1160 can have derive from ST The STM8L MCU serial model No.s of Microelectronics, such as STM8L 151G4U6；Or with deriving from Freescale's MC9S08QE4/8 serial model No.s, such as MC9S08QE4CWJ.Preferably, controller 1160 is low-power or ultra low power device, But it is alternatively used other types of device.Memorizer 1170 may include volatibility and/or non-volatile memory module In one or more, for example, read only memory (ROM), many external memories of Write once and read (WORM), random access memory (for example, SRAM, DRAM, SDRAM, DDR etc.), solid-state memory, flash memory, magnetic storage etc., or any combination of them in One or more.Memorizer 1170 is configurable to store program codes or instruction (being performed by controller), systematic parameter, operation Data, user data etc., or any combination of them.

I/O modules 1150 are configurable to serve as the interface between controller 1160 and other system units, these systems Part is provided and/or responds electromagnetic signal.In other words, I/O modules 1150 are configurable to allow 1160 monitoring system of controller Operation and control system other parts.In certain embodiments, as illustrated, I/O modules 1150 can with button 1002, Indicator 1060, pressure transducer 1070,1090 electromagnetic communication of power source 1130 and negative pressure source.I/O modules may include to be configured to One or more interfaces communicated with various parts.The interface may include standard and/or non-standard ports, such as serial port, Parallel port, EBI etc., or any combination of them.

In certain embodiments, pump group part 1000 is configurable to the operation of control system.For example, pump group part 1000 can quilt It is configured to treat and/or avoid bothering for example, by continually or unnecessarily suspending or stopping treatment in continual offer User and wishing save power, limit by the generations such as negative pressure source noise and vibration between suitable balance is provided.Figure 25 shows Top level status Figure 120 0 of the operation of pump group part according to some embodiments are gone out.In certain embodiments, controller 1140 can It is configured to perform the stream of state diagram 1200.As shown in Figure 25, in certain embodiments, the operation of pump group part can be grouped Into four general status categories：Inertia/initialization (state 1206 and 1202), activity 1210, operation 1250 and end in life-span Only (state 1214).As shown in Figure 25 and Figure 26, status categories 1210 and 1250 each include multiple states and in state Between change.

In certain embodiments, as long as power source is not connected to, is removed (as by shown in transformation 1204), or pump group part is not (for example, by pulling trip bar, trigger switch etc.) is activated, pump group part remains in state 1206.It is being maintained at the state While, pump group part can be remained inactive for.When power source is connected and/or pump group part starts for the first time, pump group part transformation To state 1202, wherein executable startup self-detection (POST).(multiple) startup self-detection may include that performing various checking to ensure that is The normal work of system, for example, test memorizer 1170 (for example, the inspection (for example, cyclic redundancy check (CRC)) of configuration processor code with Determine its integrity, test random access memory etc.), read pressure transducer 1070 whether to determine pressure value suitable In the limit, the residual capacity in readout power source or life-span (for example, cell voltage, electric current etc.) to be determining if in suitable pole In limit, test negative pressure source, etc..As illustrated, indicator 1060 (for example, LED) is configurable to indicate (example to user Such as, by flash or glisten once) pump group part just experience (multiple) POST test.

In certain embodiments, if one or more failures in (multiple) POST tests, pump group part can be converted to not Recoverable error state 1214.In this condition, pump group part can disable treatment, and indicator 1060 can be constructed and to use Person indicates to run into mistake.In certain embodiments, all indicators are configurable to holding activity.According to the seriousness of mistake, In certain embodiments, pump group part is configurable to from Fault recovery and continues operation (or be converted to fatal error state 1214).As illustrated, when running into fatal error during operation, pump group part can be converted to state 1214.Fatal error may include Program storage mistake, program code mistake (for example, running into invalid variate-value), controller operation mistake (for example, house dog Intervalometer then, and not controlled device 1160 resets), component failure (for example, inoperable negative pressure source, inoperable pressure Force transducer 1070 etc.), and any combination of them.

In certain embodiments, when being tested by (multiple) POST, pump group part can be converted to manual halted state 1216. As illustrated, this transformation can pass through disable indicator 1060 in one (for example, battery indicator 1066) and being indicated to makes User.When pump group part is converted to and is maintained at manual halted state 1216, instruction can be provided to user, such as by disabling Indicator 1062 (OK indicators) and 1064 (dressing indicators) are realized.In certain embodiments, it is maintained at manual in pump group part While halted state 1216, treatment can be stopped.For example, (for example, 1090) pump can be deactivated (or closing) to negative pressure source.At some In embodiment, instruction can be provided by disabling negative pressure source.

In certain embodiments, pump group part is configurable to carry out from time-out shape manually in response to receiving signal from switch Transformation 1224 of the state 1216 to mode of operation classification 1250 (wherein pump group part is configured to provide treatment).For example, user can Press the button to start, stop and/or restart treatment.In certain embodiments, pump group part is configurable to monitor pump group Part is maintained at the persistent period of manual halted state 1216.This can for example by keep intervalometer (firmware, software, hardware or In any combination of them) realizing, when pump group part is converted to manual halted state 1216, the intervalometer can be reset and open It is dynamic.Pump group part is configurable to automatically carry out from manual halted state 1216 to mode of operation when the persistent period threshold value is exceeded The transformation 1224 of classification 1250.In certain embodiments, such threshold value can be preset value, such as at 1 minute or less and 1 Between hour or more.In certain embodiments, threshold value can be set or changed by user.In certain embodiments, threshold value can Changed according to various modes of operation or any combination of them.For example, when pump group part, to be close to end-of-life (as explained below ) when, threshold value can be reduced.In certain embodiments, user can be controlled to suspend by activate switch (for example, pressing the button) Treat, so as to cause pump group part to carry out the transformation 1222 from mode of operation classification 1250 to manual halted state 1216.In some realities Apply in example, pump group part can be configured so that user can only suspend treatment, and disconnect power source (for example, removing battery) and stop Treatment.

In certain embodiments, pump group part is configurable to include halted state 1218.When pump group part is converted to and keeps In halted state 1218, instruction can be provided to user.For example, pump group part is configurable to disable OK indicators 1062 and draw Play dressing indicator 1064 to glisten or flash.In certain embodiments, the same of manual halted state 1216 is maintained in pump group part When, treatment can be stopped.For example, (for example, 1090) pump can be deactivated (or closing) to negative pressure source, and this is provided at pump group part to user In the instruction of halted state 1218.As explained below, in certain embodiments, pump group part is configurable to work as and retries circulation Quantity beyond when retrying the limit (transformation 1228) or when determine dutycycle beyond duty cycle limit (changing 1230) when from operation Status categories 1250 are converted to halted state 1218.In certain embodiments, transformation 1228 and 1230 can be leaked in reflection system Presence.

In certain embodiments, pump group part be configurable in response to from switch receive signal (for example, user press by Button is restarting treatment) and carry out from halted state 1218 to mode of operation classification 1250 that (wherein pump group part is configured to open Dynamic pump is providing treatment) transformation 1226.In certain embodiments, pump group part is configurable to monitoring pump group part and is maintained at time-out The persistent period of state 1218.For example, this can be by keeping intervalometer (in firmware, software, hardware or any combination of them In) realizing, when pump group part is converted to halted state 1218, the intervalometer can be reset and start.Pump group part can be constructed Into the transformation 1226 automatically carried out when the persistent period threshold value is exceeded from halted state 1218 to mode of operation classification 1250.Should Threshold value can be identical or different with the threshold value of the above manual halted state 1216.In certain embodiments, threshold value can be pre- If value, such as between 1 minute or less and 1 hour or more.In certain embodiments, threshold value can be arranged or be changed by user Become.In certain embodiments, threshold value can change according to various modes of operation or any combination of them.For example, work as pump group part When being close to end-of-life (as explained below), threshold value can be reduced.

In certain embodiments, pump group part includes both manual halted state 1216 and halted state 1218, so as to temporary Stop making a distinction between a variety of causes treated.Such separating capacity can allow pump group part and provide time-out treatment for user The instruction (for example, manual halted state 1216 and halted state 1218 can provide different instructions) of specific reasons.For example, treat Can be suspended due to user manual depression of button, in this case, pump group part can be carried out from mode of operation classification 1250 To the transformation 1222 of manual halted state 1216.Used as another example, treatment can be suspended due to detecting leakage, this In the case of, pump group part can carry out the transformation 1228 and/or 1230 from mode of operation classification 1250 to halted state 1218.At some In embodiment, pump group part is configurable to a state for including termination or time-out of the instruction in the offer for the treatment of or two Such state above.

In certain embodiments, pump group part is configurable to the residual capacity for monitoring power source or life-span (for example, by fixed Phase reading or sampling battery voltage, electric current etc.).Pump group part is configurable to indicate residual capacity to user.For example, if really Determine power source and there is normal residual capacity (for example, due to the comparison with the threshold value of 2.7V, 2.6V, 2.5V etc.), battery Indicator 1066 can be deactivated.If it is determined that power source has a low residual capacity, pump group part is configurable to for example, by drawing Play battery indicator 1066 to flash or glisten and provide instruction to user, as by shown in transformation 1220.In some embodiments In, battery indicator 1066 is configurable to intermittently or continuously flash or glisten, regardless of whether pump group part state in which is such as What or only in a particular state.

In certain embodiments, when it is determined that power source residual capacity at or approximately at critical level (for example, due to it is all The such as comparison of the threshold value of 2.4V, 2.3V, 2.2V etc.) when, pump group part is configurable to be converted to critical battery state 1212.One In a little embodiments, pump group part is configurable to be maintained at the state, until power source capacity for example by change power source or Power source is recharged and till increasing.Pump group part is configurable to disable while critical battery state 1212 is maintained at and controls Treat.Additionally, as illustrated, pump group part is configurable to for example, by all indicators of deactivation and at user indicated horsepower source In or be close to critical level.

In certain embodiments, pump group part is configurable to provide treatment after starting first up to predetermined amount of time, example Such as about 1 day, 2-10 days etc..In certain embodiments, such time period can be changed by user and/or according to various Mode of operation or any combination of them and the preset value that changes.Pump group part can be thrown aside after such time period expires. In certain embodiments, start first and (for example, can be converted to from the transformation to active state classification 1210, by pulling trip bar 1202) etc. state is reflecting.Once pump group part is activated, pump group part be configurable to monitor its holding activity it is lasting when Between.In certain embodiments, pump group part is configurable to monitor the aggregated duration being maintained in active state classification 1210. This can for example by keeping the intervalometer of persistent period as reflection (in firmware, software, hardware or any combination of them In) realizing.

When the persistent period reaches or exceeds threshold value (for example, 7 days), pump group part is configurable to be converted to end-of-life (EOL) state 1240.Treatment is disabled while pump group part is configurable in the state that is maintained at 1240 and is referred to user Show the termination of the probable life for reaching pump group part.For example, pump group part be configurable to disable all indicators and/or disable by Button.In certain embodiments, when pump group part is disposable, being converted to end-of-life status 1240 means that pump group part can quilt Throw aside.Pump group part is configurable to disable restarting for pump group part once reach end-of-life.For example, pump group part can be constructed Into not allowing to restart, even if it is also thus, this can be by read only memory that power source is disconnected and is subsequently reconnected Store instruction, value, mark etc. to realize.

Figure 26 shows the operation stream of the status categories 1250 of the pump group part 1000 according to some embodiments.Pump group part can quilt Be configured to provide treatment, the leakage in monitoring system, (multiple) indicate, etc. is provided to user.As explained below, exist In some embodiments, pump group part is configurable to the first expectation pressure-reduction level by initially attempting to set up below dressing 1010 (for example, between -5mmHg or following and -200mmHg or more, the negative pressure of such as -100mmHg) is providing treatment.At some In embodiment, first expects that pressure-reduction level can be preset value, and which is set or changed by user and/or according to various operation shapes State or any combination of them change.Once the first expectation pressure-reduction level is set up below dressing 1010, pump group part can be constructed Into deactivation negative pressure source (for example, pump).Negative pressure below dressing 1010 reduces (that is, big towards standard due to the leakage in system Air pressure is moved) when, pump group part is configurable to recover the negative pressure below dressing by starting pump, with set up below dressing the Two expect pressure-reduction level (for example, between -5mmHg or following and -200mmHg or more, the negative pressure of such as -100mmHg). In some embodiments, second expects that pressure-reduction level can be preset value, and which is set or changed by user and/or according to various behaviour Make state or any combination of them change.In certain embodiments, first and second expect that pressure-reduction level can be identical. In certain embodiments, first and second expect that pressure-reduction level can be different, i.e. it is negative that the second pressure-reduction level is smaller than first Voltage levels or the second pressure-reduction level can be more than the first pressure-reduction level.

In certain embodiments, pump group part can be converted to state from manual halted state 1216 and/or halted state 1218 1252.As explained above, this transformation can be pressed the button with/be restarted treatment and/or such as 1 by user The persistent period of hour causes when expiring.Pump group part is configurable to be converted to initial evacuation (IPD) state 1260 immediately, wherein Pump can be actuated to the first expectation pressure-reduction level is set up below dressing 1010.In certain embodiments, if below dressing Stress level expects pressure-reduction level higher than (being less than) first, then pump can be activated.Start negative pressure source to build below dressing 1010 Vertical first expectation pressure-reduction level can be referred to herein as " initial to evacuate ".Pump group part is configurable to for example, by causing OK to indicate Device 1062 flashes or glistens and disable dressing indicator 1064 and indicate which is initially evacuated to user.In some realities Apply in example, the instruction can be provided for example, by negative pressure source is started.Pump group part is configurable to by carrying out to sensor 1070 Read or sample to measure the stress level below dressing 1010.

In certain embodiments, pump group part is configurable to monitor the persistent period that pump group part is maintained at IPD states 1260. This for example can be realized by keeping intervalometer (in firmware, software, hardware or any combination of them), when pump group part changes During to IPD states 1260, the intervalometer can be reset and start.In certain embodiments, produced by pump to save power, restriction Raw noise and/or vibration etc., pump group part are configurable to for initial evacuation to stop a time period, then retry and initially take out It is empty.The function can for example be saved the power of battery and be allowed instantaneous and/or non-momentary to leak in the situation for not having user to intervene Under be solved or allow user repair leakage (for example, stretch dressing, repair sealing, check one or more connection, etc.).

In certain embodiments, threshold value (for example, 30 seconds) is equal to or over when the persistent period for being maintained at IPD states 1260 When, pump group part is configurable to carry out the transformation 1264 to state 1266.In certain embodiments, threshold value can be preset value, For example between 5 seconds or less and 5 minutes or more.In certain embodiments, threshold value can be set or changed by user.One In a little embodiments, threshold value can change according to various modes of operation or any combination of them.In certain embodiments, pump group part It is configurable to disable pump when transformation 1264 is carried out.It is first set up below dressing 1010 that pump group part is configurable to monitor Expect negative pressure and carry out number of attempt (for example, by keeping enumerator, the enumerator can 1252 time replacements of state and 1270 times renewals of waiting state).In certain embodiments, pump group part is configurable to provide finite number of time or maximum times IPD retries trial, for example to save power.Preferably, pump group part be configurable to provide finite number of time continuous IP D retry Attempt, but pump group part be configurable to provide finite number of time discontinuous IPD retry trial or IPD both continuously and discontinuously retry The mixing of trial.It can be 1,2,3,4,5 etc. that IPD retries the threshold value of trial.In certain embodiments, threshold value can be default Value.In certain embodiments, threshold value can be set or changed by user.In certain embodiments, threshold value can be according to various operations State or any combination of them are changing.

In certain embodiments, pump group part is configurable to determine that carried out IPD retries trial for 1266 times in state Whether number of times is equal to or over threshold value (for example, retrying trial 1 time).The number of times that trial is retried in the IPD for being carried out is equal to or super In the case of going out threshold value, pump group part is configurable to carry out the transformation 1228a to halted state 1218, in halted state 1218, Treatment is suspended or stops, as mentioned above.Otherwise, pump group part is configurable to carry out the transformation 1268 to waiting state 1270. In certain embodiments, pump group part is configurable in 1266 times deactivation negative pressure sources of state, and this can provide pump group to user Part is converted to the instruction of state 1266.

In certain embodiments, pump group part is configurable in 1270 times deactivation pumps of waiting state, so as to treatment is suspended One time period (for example, between 1 second or less and 1 minute or more, such as 15 seconds).This can for example by keeping intervalometer (in firmware, software, hardware or any combination of them) realizing, when pump group part is converted to waiting state 1270, this is fixed When device can be reset and start.The time period under waiting state 1270 can be it is default or variable (for example, automatically or By user).In certain embodiments, the time period can be changed according to various modes of operation or any combination of them.Pump Component is maintained at the time period of waiting state 1270 and can be reduced when waiting state 1270 is converted to every time or increase (example Such as, be multiplied by between 0.1 or less and 4.0 or more, such as 2 factor).Time period can continuously be converted to wait shape every time It is reduced during state 1270 or increases.Time period can be reduced or increase, until its be equal to or over threshold value (for example, at 1 second or with It is lower and between 5 minutes or more, such as 4 minutes).Additionally, the time period can be converted to monitoring pressure state 1280, change in one's hands Dynamic halted state 1216, it is reset to initial value when being converted to halted state 1218 etc..

In certain embodiments, pump group part is configurable to indicate that pump group part is waited for 1270 to user.Example Such as, pump group part is configurable to cause OK indicators 1062 to glisten or flashes and disable dressing indicator 1064.In some enforcements In example, disable pump and the instruction that pump group part is waited for 1270 can be provided.When expiring the time period being waited for, pump Component is configurable to carry out the transformation 1272 from waiting state 1270 to IPD states 1260, in IPD states 1260, pump group part Can attempt the first expectation pressure-reduction level is set up below dressing 1010.In certain embodiments, pump group part is configurable to guarantee Pressure-reduction level below dressing is maintained on certain level of security.For example, pump group part is configurable to below dressing 1010 Pressure-reduction level be maintained at the safe water of between -150mmHg or following and -250mmHg or more (such as -225mmHg) On flat.

In certain embodiments, when it is built stand in below dressing 1010 first expectation pressure-reduction level when, pump group part can quilt It is configured for the transformation 1276 to monitoring state 1280.Pump group part is configurable to IPD weights are reset when transformation 1276 is carried out The number of times of prelibation examination.Pump group part be configurable to for example, by cause OK indicators 1062 to flash or glisten and disable dressing instruction Device 1064 and to user indicate be converted to monitoring state 1280.While monitoring state 1280 are maintained at, pump group part can quilt It is configured to disable pump (which can provide instruction of the pump group part in monitoring state 1280 to user) and regularly or continuously Stress level below monitoring dressing 1010.Pump group part is configurable to by being read out sensor 1070 or sampling survey Stress level below amount dressing 1010.

In certain embodiments, pump group part is configurable to determine whether dressing is caused for example due to the leakage in system Pressure-reduction level below 1010 is decreased to reach and/or beyond (for example, becoming less than) threshold value.Threshold value can from -10mmHg or Select below and in the range of -100mmHg or more, such as -60mmHg.In certain embodiments, threshold value can be by using The preset value that person is set or changed and/or is changed according to various modes of operation or any combination of them.If it is determined that reaching Or exceeding threshold value, pump group part is configurable to recover the pressure-reduction level below dressing 1010.In certain embodiments, pump group part can It is configured to re-establish the first expectation pressure-reduction level or sets up another different pressure-reduction level.This can be by carrying out to dimension Hold the transformation 1282 of evacuation (MPD) state 1290 to realize.

In certain embodiments, pump group part is configurable to start pump while pump group part is maintained at MPD states 1290 To set up the expectation pressure-reduction level (for example, the first aspiration level) below dressing 1010.Pump group part is configurable to for example lead to Cross cause OK indicators 1062 to flash or glisten and disable dressing indicator 1064 and instruction is provided to user.In some enforcements In example, the pump group part for starting negative pressure source can provide the instruction that pump group part is converted to state 1290 to user.In some embodiments In, pump group part is configurable to 1290 time start when ratio when pump when IPD state 1264 time start produce more in MPD states when pump Few noise and vibration.For example, the difference in noise level can be between 1dB or following and 30dB or more, such as about 7dB, about 20dB etc..Used as another example, the difference in noise level can be in 30dB or with down between 80dB or more, example Such as about 45dB, about 50dB, about 65dB etc..

In certain embodiments, pump group part is configurable to monitor its persistent period for being maintained at MPD states 1290.This can For example by keeping intervalometer (in firmware, software, hardware or any combination of them) realizing, when pump group part carry out to During the transformation 1282 of MPD states 1290, the intervalometer can be reset and start.In certain embodiments, in order to save power, limit The noise and/or vibration etc. produced by pump is made, pump group part is configurable to maintain evacuation to stop a time period, Ran Houchong Examination is initial to be evacuated and/or maintains to evacuate.The function can for example be saved the power of battery and be allowed instantaneous and/or non-momentary to leak It is solved or allows user to repair leakage (for example, stretch dressing, repair sealing, check in the case of without user intervention One or more connections, etc.).

In certain embodiments, when the persistent period under MPD states 1290 equal to or over threshold value (for example, at 5 seconds or Value between below and 5 minutes or more, such as 10 seconds) and dressing 1010 below stress level not up to expect negative pressure water At ordinary times, pump group part is configurable to carry out the transformation 1292 to state 1294.Threshold value can be by user be set or changed and/ Or the preset value changed according to various modes of operation or any combination of them.In certain embodiments, pump group part can be by structure Cause to disable pump when transformation 1292 is carried out, this can provide the instruction just changed by pump group part to user.Pump group part can quilt It is configured to monitor the number of times of the MPD trials carried out for the expectation negative pressure set up below dressing 1010 (for example, by keeping counting Device, the enumerator can be reset in state 1252 times and/or when transformation 1228b is carried out and can when transformation 1296 is carried out It is updated).In certain embodiments, pump group part is configurable to offer finite number of time or maximum times MPD and retries trial (for example, to save power).Preferably, pump group part be configurable to provide finite number of time continuous N PD retry trial, but pump Component is configurable to provide the discontinuous MPD of finite number of time and retries trial or the mixing for retrying trial both continuously and discontinuously. It can be 1,2,3,4,5 etc. that MPD retries the threshold value of trial.In certain embodiments, threshold value can be arranged or changed by user The preset value for becoming and/or being changed according to various modes of operation or any combination of them.Pump group part be configurable to IPD and MPD retries the number of times of trial and is set as identical or different value.Pump group part is configurable to what is carried out in 1294 times determinations of state Whether MPD retries the number of times of trial equal to or over threshold value (for example, retrying trial 3 times).Trial is retried in the MPD for being carried out Equal to or in the case of threshold value, pump group part is configurable to carry out the transformation 1228b to halted state 1218 number of times, temporary Stop state 1218, treatment is suspended or stops, as mentioned above.Otherwise, pump group part is configurable to carry out to waiting state 1270 Transformation 1296, in waiting state 1270, treatment is suspended or stops, as mentioned above.Alternatively, pump group part be configurable to into Transformation of the row to IPD states 1260 or MPD states 1290.

In certain embodiments, pump group part is configurable to the stress level below the dressing and reaches or beyond (for example, becoming Must be more than) expect during pressure-reduction level, to carry out the transformation 1284 to monitoring state 1280.Pump group part is configurable to changed The number of times that MPD retries trial is reset when 1284.

In certain embodiments, pump group part is configurable to the dutycycle for monitoring negative pressure source (for example, pump).Pump group part can quilt It is configured to regularly and/or continuously monitor dutycycle.Duty ratio measuring value can reflect the various modes of operation of system, for example, let out The flow rate (for example, air, liquid and/or solid exudate etc.) of the existence and/or seriousness of leakage, the fluid suctioned out from wound Deng.For example, duty ratio measuring value may indicate that the existence of high-leakage, and pump group part be configurable to indicate the state and/or The interim operation for stopping or suspending pump, to save power.The function for example can save the power of battery and allow it is instantaneous and/or Non-momentary leakage is solved or allows user repairing leakage in the case of no user intervention and (for example, stretches dressing, repaiies Reason is sealed, checks one or more connections, etc.).

In certain embodiments, pump group part is configurable to regularly monitor dutycycle, such as per 10 seconds or following and 5 Between minute or more once.In certain embodiments, pump group part is configurable to dutycycle of monitoring per minute.This can lead to Cross holding intervalometer (in firmware, software, hardware or any combination of them) to realize, the intervalometer can be configured to per point Clock expires once (for example, as by interruption or via poll instruction) and can be restarted (for example, by crossing interruption). In some embodiments, the time interval for measuring dutycycle can be preset value, and which is set or changed by user and/or according to each Plant mode of operation or any combination of them change.In certain embodiments, pump group part is configurable to when pump group part is in behaviour Make status categories 1250 (that is, in state 1260,1266,1270,1280,1290,1294 any one and/or in any state Between any transformation) when monitor dutycycle because pump group part is configured to start pump in the status categories.In some enforcements Example in, pump group part be configurable to when pump group part in mode of operation classification 1250 particular state and/or state transformation or Dutycycle is monitored during the subset of state and/or state transformation.In certain embodiments, pump group part is configurable at the pump group part In the particular state and/or state of active state classification 1210 change, state and/or state change subset or all states And/or state transformation, or any state disclosed herein and/or state transformation any combinations when monitor dutycycle.As schemed Shown in 26, pump group part can carry out the transformation 1302 of any one from state 1260,1266,1270,1280,1290,1294 And/or in any one state to the transformation between state 1300, in state 1300, pump group part determines the pump during the time of passage Dutycycle.Dutycycle can be determined according to following formula：

DC = t / T, (2)

Wherein, DC is dutycycle, and t is persistent period of the negative pressure source in activity, and T is by total time for considering. In the case of dutycycle (that is, T=60 seconds) of monitoring per minute, dutycycle can be expressed (for example, in percentage) and be：

DC=(run time/60 of pump during the time of passage) * 100% (3).

In order to determine dutycycle, pump group part is configurable to monitor pump activity (for example, pump operation time) and/or inertia Persistent period.

In certain embodiments, pump group part be configurable to compare determined by dutycycle and duty cycle threshold, the threshold value Can select from the scope between 1% or less and 50% or more.The existence that relatively can be leaked in such as instruction system. In other words, if pump holding activity within the time period so that duty cycle threshold is reached or exceeds, and pump can be with intensive work To overcome leakage.In this case, pump group part is configurable to the offer for stopping or suspending treatment.Pump group part can be constructed Into for example, by deactivation negative pressure source, to the instruction of the positive intensive work of user offer pump, (for example, dutycycle exceeds dutycycle Threshold value).In certain embodiments, duty cycle threshold can be set or changed by user and/or according to various modes of operation Or any combination of them and the preset value that changes.As shown in Figure 26, pump group part be configurable to compare determined by account for Empty ratio is with duty cycle threshold (for example, 9%).Pump group part is configurable to for example, by keeping and updating overload enumerator monitor Beyond the quantity of the dutycycle of threshold value, when pump group part is converted to IPD states 1260 from state 1252, the enumerator can be weighed Put.

In certain embodiments, pump group part is configurable to update overload enumerator for 1300 times in state.If determined Dutycycle without departing from duty cycle threshold, pump group part can make overload enumerator successively decrease.In certain embodiments, transship enumerator Minima can be set to zero, i.e. overload enumerator can not be changed into negative., whereas if determined by dutycycle equal to or over accounting for Than threshold value, pump group part is incremented by can overload enumerator to sky.

In certain embodiments, pump group part is configurable to the sum for monitoring the dutycycle equal to or over duty cycle threshold Or accumulative total.The method can help to eliminate or equalize duty cycle deviations, for example to prevent what is can caused by moment leakage One or several error loops interrupt treatment.In certain embodiments, pump group part is configurable to monitoring beyond dutycycle threshold The continuous or discontinuous dutycycle of value.In certain embodiments, threshold value can be set or changed by user and/or root The preset value changed according to various modes of operation or any combination of them.If it is determined that beyond the dutycycle of duty cycle threshold Quantity beyond overloading threshold (for example, the quantity between 1 and 60 or more, for example 30), pump group part be configurable to carry out to The transformation 1230 of halted state 1216, in halted state 1216, treatment is aborted or suspends, as mentioned above.In some embodiments In, pump group part is configurable to disable negative pressure source, and this can provide instruction (for example, the duty of the positive intensive work of pump to user Than beyond overloading threshold).If be not defined as beyond overloading threshold beyond the quantity of the dutycycle of duty cycle threshold, pump group part can It is configured to carry out transformation 1304 and be maintained in mode of operation classification 1250.In certain embodiments, pump group part can be constructed Change between 1302 states being located into returning to equal state and/or carrying out changing in pump group part.In certain embodiments, pump Component is configurable to be converted to different states and/or changes between states.

In certain embodiments, pump group part is further configured to：While pump group part is in mode of operation classification 1250, such as Fruit user presses the button 1002, then stop or suspend treatment.In certain embodiments, pump group part is configurable to change in one's hands Dynamic halted state 1216.

Figure 27 illustrates another state diagram of the operation of the pump group part 1000 according to some embodiments.In some embodiments In, controller 1140 is configurable to the stream for performing state diagram 1400.In certain embodiments, stream 1400 can be substantially similar to Stream shown in Figure 25-26.State 1402 corresponds to state 1202, and state 1406 corresponds to state 1260, status categories 1410 Corresponding to status categories 1210, state 1414 corresponds to state 1214, and state 1416 corresponds to state 1216,1418 correspondence of state In state 1218, corresponding to transformation 1220, corresponding to transformation 1222, transformation 1424 is corresponding to transformation for transformation 1422 for transformation 1420 1224, transformation 1426 is corresponding to transformation 1226, and state 1440 corresponds to state 1240.Additionally, 1450 correspondence of status categories In status categories 1250, state 1460 corresponds to state 1260, and corresponding to transformation 1264, state 1466 is corresponded to and turned for transformation 1464 Become 1266, transformation 1468 corresponds to state corresponding to transformation 1228a, state 1470 corresponding to transformation 1268, transformation 1428a 1270, and change 1472 corresponding to transformation 1272.Additionally, transformation 1476 is corresponding to transformation 1276, state 1480 corresponds to shape State 1280, transformation 1482 correspond to state 1290 corresponding to transformation 1282, state 1490, change 1492 corresponding to transformation 1292, State 1494 corresponds to state 1294, and transformation 1496 is corresponding to transformation 1296, and changes 1428b corresponding to transformation 1228b.

In certain embodiments, pump group part is configurable under MPD states 1490 set up below dressing 1010 and expects Dutycycle is monitored after pressure-reduction level.In certain embodiments, pump group part also contemplates for being maintained at IPD states 1460 in pump group part While the pump movable persistent period.As illustrated, the device is configurable to carry out the transformation from MPD states 1490 1484.Transformation 1484 can be similar to transformation 1284, but not be to be to a transition directly to IPD states 1480, and pump group part is configurable to 1500 times monitoring dutycycles of state.In certain embodiments, pump group part is configurable to be maintained at monitoring state in pump group part Dutycycle is monitored during the cumulative time section of 1480 and MPD states 1490.In certain embodiments, pump group part is configurable to Adjacent upper one or previous monitoring and MPD monitor dutycycle during circulating in cumulative time section.For example, just in transformation To before state 1500, pump group part can keep time duration X for 1490 times in MPD states (within the time, pump is activity).This Outward, it is assumed that just before MPD states 1490 are converted to, pump group part keeps persistent period Y for 1480 times (in this phase in monitoring state Between, pump is inactive), dutycycle (DC) can be expressed (for example, in percentage terms) and be：

DC = 100% * [X / (X + Y)]. (4)。

In order to determine dutycycle, pump group part is configurable to monitor pump in movable and/or inactive persistent period.

In certain embodiments, pump group part be configurable to compare determined by dutycycle with duty cycle threshold (for example, 9%), as mentioned above.In certain embodiments, threshold value can be set or changed by user and/or according to various modes of operation Or any combination of them and the preset value that changes.If it is determined that dutycycle is less than threshold value, pump group part be configurable to carry out to The transformation 1502 of monitoring state 1480., whereas if determining that dutycycle is equal to or over threshold value, pump group part is configurable to carry out To the transformation 1504 of state 1506.In certain embodiments, pump group part can provide dutycycle beyond threshold for example, by pump is disabled The instruction of value.

In certain embodiments, pump group part is configurable to monitor dutycycle equal to or over the total time of threshold value or accumulative Time.The method can help to eliminate or equalize duty cycle deviations, so as to one that for example prevents to be caused by moment leakage Or several error loops interrupt treatment.Monitoring can be by keeping intervalometer (in firmware, software, hardware or their any group In conjunction) realizing, the intervalometer can be restarted (for example, when changing 1476) and renewal (for example, under state 1506). In certain embodiments, pump group part is configurable to determine that whether dutycycle is equal to or over threshold in certain cumulative time section Value, the time period can be compared with aggregated duration threshold value.Threshold value can be between 5 minutes or less and 2 hours or more In the range of select (such as 30 minutes).In certain embodiments, threshold value can be set or changed by user and/or according to Various modes of operation or any combination of them and the preset value that changes.If cumulative time section is equal to or over threshold value, pump group Part is configurable to carry out the transformation 1508 to halted state 1418, under a halt condition, pump group part be configurable to stop or The offer for the treatment of is provided.In certain embodiments, pump group part can indicate this transformation to user for example, by pump is disabled.Instead It, if it is determined that cumulative time section is less than threshold value, and pump group part is configurable to carry out the transformation 1510 to monitoring state 1480.Pump Component is configurable to for example, by causing OK indicators 1062 to flash or glisten and disable dressing indicator 1064 and to use Person indicates transformation 1510.

Figure 28 illustrates the figure 1600 that the dutycycle for describing the pump group part 1000 according to some embodiments determines.X-axis is represented Time, Y-axis represent pressure.In certain embodiments, pump group part is configurable to set up -100mmHg's below dressing 1010 Pressure-reduction level, as by represented by position 1606.For example, this can be carried out under state 1260 during initial evacuation.Pump group Part is configurable to monitor the pressure-reduction level below dressing 1010.For example, this can be carried out under monitoring state 1280.As schemed Show, pump group part can monitor the pressure in the time period a represented by interval 1602.Pressure-reduction level below dressing 1010 can be at any time Between passage and decay (for example, due to the leakage in system), as by shown in line 1620.

In certain embodiments, pump group part is configurable to when decline of pressure is to reach or beyond the threshold of about -70mmHg Recover during value (as by represented by position 1608) or re-establish the pressure-reduction level below dressing 1010.In some embodiments In, pump group part is configurable to start pump, as by represented by line 1622.For example, this can be by being converted to maintenance evacuated 1290 carrying out.As illustrated, pump group part can start pump up to persistent period b (1604), until being built below dressing 1010 again The pressure-reduction level of vertical -100mmHg.Pump group part is configurable to reach at position 1610 in the stress level below dressing 1010 To pump is disabled during -100mmHg.For example, this can be carried out by being converted to monitoring state 1280.The time period shown in 1600 Dutycycle (DC) in (that is, a+b) can be expressed (for example, in percentage terms) and be：

DC = 100% * [b / (a + b)]. (5)。

Figure 29 shows normal (for example, No leakage or low leakage) operation 1700 of some embodiments of pump group part 1000 Non-limiting example.Pump group part is configurable to set up below dressing 1010 expects pressure-reduction level, as shown in frame 1702. Pump group part can be configured so that the stress level below the dressing 1010 rises into and exceed aspiration level (for example, the first setting Point value, such as -70mmHg) when, negative pressure source (for example, pump) will be activated and will start to operate with by the pressure below dressing 1010 Power level is decreased to expected value.For example, the area that the expected value can be about between the first set-point value and the second set-point value In or be of about the second set-point value (for example, -100mmHg).In certain embodiments, this can be in initial evacuated 1260 realize.

In certain embodiments, when the stress level below the dressing 1010 reaches expected value, pump group part is configurable to Disable pump and monitor the stress level below dressing, as shown in frame 1704.For example, this can be in 1280 times realities of monitoring state It is existing.Pump group part is configurable to regularly or continuously monitor dressing for example, by reading sensor 1070 or sampling which Stress level below 1010.According to the pressure for monitoring, pump group part can determine in frame 1706 pump whether need to be activated or Restart to re-establish the expectation pressure-reduction level below dressing 1010.If the pressure for monitoring is confirmed as low (example Such as, less than or be less than or equal to the first set-point value), pump group part be configurable to start pump, as shown in frame 1708.Example Such as, this can be realized by being converted to MPD states 1290., whereas if the stress level for monitoring is not determined to low (example Such as, more than or be more than or equal to the first set-point value), pump group part be configurable to continue monitoring dressing 1010 below pressure Level.During the operation stream, pump group part is configurable to indicate which just in normal operating to user.Such as the institute in 1060a Show, pump group part can start OK indicators 1062 or cause OK indicators 1062 to flash or glisten, and this is depicted as 1062a.Additionally, Pump group part can disable dressing indicator 1064 and battery indicator 1066, and this is depicted as 1064a and 1066a respectively.

Figure 30 shows the non-limiting of the operation 1800 of some embodiments of pump group part 1000 in the presence of high-leakage Example.As explained above with described in Figure 29, pump group part is configurable to the expectation pressure-reduction level set up below dressing 1010, such as in frame Shown in 1802.In certain embodiments, when the stress level below the dressing 1010 reaches expected value, pump group part can be constructed Into disabling pump and monitoring the stress level below dressing, as shown in frame 1804.Pump group part is configurable to for example, by reading Take sensor 1070 or which is sampled and the stress level below dressing 1010 regularly or is continuously monitored.According to what is monitored Stress level, pump group part can determine that whether pump needs to be activated or restart to bear to re-establish the expectation below dressing 1010 Voltage levels.If the stress level for monitoring is confirmed as low (for example, less than or less than or equal to the first set-point value), Pump group part is configurable to start pump, as shown in frame 1808.Once desired pressure is re-established below dressing 1010 1280) power level, the pressure-reduction level that pump group part can restart to monitor below dressing (for example, are converted to monitoring state.

In certain embodiments, due to the presence of at one in system or many places leakage, pump group part 1010 be configurable to into Row is monitored and restarts multiple circulations of pump.During the operation stream, pump group part is configurable to indicate pump group to user Part is just in normal operating.As shown in 1060b, pump group part can start OK indicators 1062 or cause OK indicators 1062 to flash Or flash of light, this is depicted as 1062b.Additionally, pump group part can disable dressing indicator 1064 and battery indicator 1066, this difference It is depicted as 1064b and 1066b.Pump group part is configurable to continuously or periodically determine the whether positive too frequent ground pump of pump Send, as shown in frame 1810.As illustrated, in certain embodiments, pump group part be configurable to using dutycycle as with In it is determined that the alternative that whether just excessively frequently pumping of pump.For example, pump group part is configurable to determine whether pump is just " high-strength Degree work ", i.e. determine whether pump is opened more than threshold duration, the 9% of such as total treatment time.In other words, pump group part can It is configured to determine whether the dutycycle of pump reaches or beyond duty cycle threshold.

In certain embodiments, pump group part is configurable to work as and determines pump intensive work more than a persistent period (for example, Pump is opened more than about 2 hours/day, or opens exceeding predetermined time amount) when stop or suspend the operation of pump, even if setting up the phase Hope pressure-reduction level (for example, the second set-point value).As shown in frame 1812, pump group part is configurable to determine whether pump is high-strength The persistent period of degree work 30 minutes or more.For example, pump group part is configurable to determine and monitored in past 30 minutes A dutycycle (or multiple dutycycles) whether exceed duty cycle threshold.For example, whether pump group part can determine that pump past About 2 minutes are had turned in 30 minutes 42 seconds or longer again, this corresponds to 9% duty cycle threshold.

In certain embodiments, pump group part is configurable to when it is determined that suspend or stop treatment during the positive intensive work of pump, As shown in frame 1814.Pump group part is also configured to open " leakage alarm " indicator.As shown in 1060c, pump group Part can start dressing indicator 1064 or cause dressing indicator 1064 to flash or glisten, and this is depicted as 1064b, and disables OK indicators 1062 and battery indicator 1066, this is depicted as 1062c and 1066c respectively.In order to restart treatment, use Person may need dressing of flattening, and repair leakage, and/or be again started up pump.In certain embodiments, due to time-out etc., can pass through Press the beginning on pump or operation button and be again started up pump.

In the case of there is the leakage of at one or many places in dressing, in certain embodiments, pump group part 1000 can be programmed Or be otherwise configured to stop or suspend to control when not up to the second set-point value after the scheduled operating time of pump amount Treat.For example, in certain embodiments, if pump has continuously run X minutes and not up to the second set point pressure value, pump group part Alarm (which may include LED indicator, " detecting leakage " LED indicator 1064 or other alarms) can be started and time-out is controlled Treat.In certain embodiments, predetermined time amount can be the general plan persistent period of the about negative pressure treatment of the system 5%, or The general plan persistent period of the negative pressure treatment of the person system from about 3% or with down to about 15% or more.In some enforcements In example, predetermined time amount can be about 9 minutes, or from about 4 minutes or with down to about 40 minutes or more, or from about 6 minutes to about 10 minutes.

Figure 31 shows the unrestricted of the operation 1900 of some embodiments of pump group part 1000 in the presence of very high-leakage Property example.As explained above with described in Figure 29, pump group part is configurable to the expectation pressure-reduction level set up below dressing 1010, such as exists Shown in frame 1902.In certain embodiments, when the stress level below the dressing 1010 reaches expected value, pump group part can be by structure Cause to disable pump and monitor the stress level below dressing, as shown in frame 1904.Pump group part be configurable to for example, by Read sensor 1070 or which is sampled and the stress level below dressing 1010 regularly or is continuously monitored.According to monitoring Stress level, pump group part can determine that whether pump needs to be activated or restart to re-establish the expectation below dressing 1010 Pressure-reduction level.If the stress level for monitoring be confirmed as it is low (for example, less than or less than or equal to the first set point Value), pump group part is configurable to start pump, as shown in frame 1908.During the operation stream, pump group part be configurable to User indicates pump group part just in normal operating.As shown in 1060d, pump group part can start OK indicators 1062 or cause OK Indicator 1062 flashes or glistens, and this is depicted as 1062d.Additionally, pump group part can disable dressing indicator 1064 and battery refers to Show device 1066, this is depicted as 1064d and 1066d respectively.

In certain embodiments, as the leakage of at one or many places (is for example leaked at, with very high flow rate), pump Component may not reach expectation pressure-reduction level and/or the second set-point value below dressing 1010.If in predetermined behaviour After making time quantum, pressure-reduction level is not up to expected below dressing, pump group part is configurable to stop or suspend pump, such as in frame Shown in 1914.For example, this can be realized by being converted to waiting state 1270.In certain embodiments, the pump behaviour of scheduled volume The time of work can be 10 seconds (as shown in Figure 31).In certain embodiments, the pump operated time of scheduled volume can be from big About 5 seconds or with down to about 60 seconds or more.

In certain embodiments, pump group part is configurable to provide retrying for finite number of time in time-out or before stopping treatment Circulation.As shown in frame 1920,1922 and 1924, pump group part be configurable to stop or suspend treatment (1914) and/or Circulation is retried through three before starting the such as alarm of " leakage alarm ".Some embodiments of pump group part can suspend treatment And/or start alarm before retry through two circulation, four retry circulate etc..As shown in 1060e, pump group part can be opened Dynamic dressing indicator 1064 causes dressing indicator 1064 to flash or glisten, and this is depicted as 1064e, and disables OK instructions Device 1062 and battery indicator 1066, this is depicted as 1062e and 1066e respectively.

Figure 32 shows the unrestricted of the operation 2000 of some embodiments of pump group part 1000 in the presence of high leakage Property example.Pump group part is configurable to quickly enter treatment time-out or suspending mode, in order to avoid battery is wasted, to attempt to solve high stream Rate leakage problem.As shown in frame 2001, pump group part can be unlocked, and this can for example by being converted to mode of operation classification 1250 realizing.As explained above with described in Figure 29, pump group part is configurable to the expectation pressure-reduction level set up below dressing 1010, As shown in frame 2002.

In certain embodiments, if leakage is high, for example, it is unlocked when pump, but is not already connected to dressing or does not correctly connect When being connected to dressing, pump group part is configurable to operate predetermined time amount, while attempt arranging the pressure below dressing 1010 arriving Expect pressure-reduction level (for example, certain value in the about second set-point value or the interval between the first and second set-point values). Pump group part is configurable to stop when the predetermined time amount is expired or suspends treatment.For example, this can be by being converted to wait shape State 1270 is realizing.As illustrated, pump group part is configurable to make pump operated 30 seconds.If the dressing 1010 during the time period The pressure of lower section is not set to expectation negative pressure, and pump group part (for example, can be reached into jabber mode 2020 up to another predetermined time amount 15 seconds, as shown in Figure 32).During the operation stream, pump group part is configurable to just indicating pump group part to user Often operate.As shown in 1060f, pump group part can start OK indicators 1062 or cause OK indicators 1062 to flash or glisten, This is depicted as 1062f.Additionally, pump group part can disable dressing indicator 1064 and battery indicator 1066, this is depicted respectively For 1064f and 1066f.

In certain embodiments, pump group part be configurable to provide finite number of time retry circulation to set up under dressing 1010 The expectation pressure-reduction level of side.As illustrated, after first time attempts (or additional trial of any number of times), pump group part can be by structure Cause to set up or re-establish the expectation pressure-reduction level below dressing, as shown in frame 2002.In certain embodiments, such as exist Shown in frame 2014, if pump group part first time attempt after operate another predetermined time amount and not by dressing 1010 below Pressure is arranged to aspiration level (for example, the about second set-point value or interior to the interval between the first and second set-point values Certain value), pump group part is configurable to stop or suspend treatment and does not retry evacuation.Pump group part is configurable to be maintained at termination Or halted state, it is restarted until pump group part (for example, due to time-out, as user is pressed the button, etc.).Pump group part It is configurable to start alarm in this condition.During the operation stream, pump group part is configurable to indicate to deposit to user At one or the leakage of many places.As shown in 1060g, pump group part can start dressing indicator 1064 or cause dressing indicator 1064 flicker or glisten, this is depicted as 1064g, and disables OK indicators 1062 and battery indicator 1066, this respectively by It is depicted as 1062g and 1066g.

Through the specification and claims of present specification, the change of word " including " and "comprising" and these words Type for example " is included " and " including " refers to " including but not limited to ", and be not intended to (and not) exclude other parts, add Plus part, part, integer or step.

Through the specification and claims of present specification, odd number covers plural number, unless context indicates otherwise.It is special Not, when using indefinite article, present specification is interpreted as considering plural number and odd number, unless the context otherwise institute Refer to.Additionally, in certain embodiments, term " about " means to represent the value in the 10% of the value, unless herein with which Its mode is illustrated.

Threshold value provided in this article, the limit, the persistent period, time-out, retry any value for counting etc. and be not intended to as absolute Value and therefore can be approximation.Additionally, any threshold value provided in this article, the limit, the persistent period, time-out, retry counting etc. Can be fixed value or automatically or by user changing.And, as used herein, relative to reference value such as Beyond, more than, less than etc. relative terms be also intended to cover equal to the reference value.For example, can cover beyond the reference value for positive number Equal to or more than the reference value.

With reference to particular aspects, embodiment or example description feature, integer, characteristic, compound, chemical part or in groups should It is interpreted as suitable for any other aspect described herein, embodiment or example, unless incompatible with which.Present specification All features, and/or disclosed any method disclosed in (including any claims, specification digest and accompanying drawing) Or all steps of process can be combined with any combinations, but including at least in wherein such feature and/or step A little mutually exclusive combinations.Protection is not limited to the details of any previous embodiment.Protection extends to (include appointing in present specification What claims, specification digest and accompanying drawing) disclosed in feature in any novel feature or any novel combination, or Any novel step or any novel combination of the step of person extends to disclosed any method or process.

Although having been described for some embodiments, these embodiments are only provided by way of example, and are not intended to limit guarantor Shield scope.In fact, novel method as herein described and system can be embodied with various other forms.Furthermore, it is possible to make this Various omissions, replacement and change in the form of the method and system described in text.It should be understood by those skilled in the art that at some In embodiment, step shown in accompanying drawing is may differ from diagram and/or the actual step taken in the disclosed process.According to reality Apply some of example, procedure described above to be removed, other steps can be increased.Therefore, the scope of the present disclosure is only intended to Limited by reference to claims.Claims and its equivalents are intended to the model that will fall in protection object Such form or modification in enclosing and being spiritual.For example, the various parts shown in accompanying drawing can processor, controller, ASIC, Software and/or firmware are embodied as on FPGA and/or specialized hardware.And, the feature and attribute of disclosed specific embodiment can To combine to form additional embodiment by different way, all these embodiments are both fallen within the scope of the present disclosure.Although this public affairs Open there is provided some preferred embodiments and application, but for it would be apparent to one of skill in the art that other embodiments （Including the embodiment of the whole not provided in feature and advantage set forth herein）Also fall in the scope of the present disclosure.Therefore, originally Scope of disclosure is intended to solely by reference to claims limit.

Claims

1. a kind of equipment for negative pressure to be applied to wound, including：

Dressing, the dressing are configured to be placed on the wound and fluid substantially impermeable are formed on the wound Sealing；

Negative pressure source, the negative pressure source are configured to couple to the dressing；And

Controller, the controller are configured to：

Start the negative pressure source, the negative pressure source is suspended into a time period；And restart when expiring the time period described negative Potential source；

Multiple dutycycles of the negative pressure source are monitored within the multiple continuous and equal persistent period；And

Determine whether the dutycycle in the plurality of dutycycle exceeds duty cycle threshold,

The negative pressure source includes pump, wherein the pump includes micropump.

2. equipment according to claim 1, wherein when the dutycycle is reflected in the plurality of continuous and equal lasting Between in a persistent period in the negative pressure source in activity time quantum.

3. equipment according to claim 1, wherein the controller is further configured to：

It is determined that whether one group of dutycycle from the plurality of dutycycle exceeds duty cycle threshold；And

Determine the quantity of dutycycle in this group of dutycycle whether beyond overloading threshold.

4. equipment according to claim 3, wherein the controller be further configured to determine it is described in this group of dutycycle Whether dutycycle is continuous.

5. equipment according to claim 3, wherein the controller is configured to determine this group of duty in the following manner Than whether exceeding the duty cycle threshold：

The count-up counter when the controller determines the dutycycle beyond the duty cycle threshold；And

Successively decrease the enumerator when the controller determines the dutycycle without departing from the duty cycle threshold.

6. equipment according to claim 3, wherein the overloading threshold includes 30.

7. equipment according to claim 2, wherein the persistent period include 1 minute.

8. equipment according to claim 1, wherein the duty cycle threshold includes 9%.

9. equipment according to claim 1, wherein the controller be also configured to it is the plurality of continuous and equal The plurality of dutycycle is monitored continuously in persistent period.

10. equipment according to claim 1, wherein the equipment also includes being configured to for the negative pressure source to suspend the time Section switch, and the controller be also configured to the time period expire when restart the negative pressure source.

11. equipment according to claim 10, wherein the time period is variable.

12. equipment according to claim 10, negative pressure source described in wherein at least are closed in the shell including outer surface, And the switch includes the button on the outer surface of the shell.

13. equipment according to claim 1, wherein the controller is further configured to the instruction for providing mode of operation.

14. equipment according to claim 13, wherein the mode of operation includes determining that the dutycycle is accounted for beyond described Sky is than threshold value, and the instruction includes disabling the negative pressure source.

15. equipment according to claim 14, wherein the leakage in the instruction sealing.

16. equipment according to claim 13, wherein the mode of operation includes whether the negative pressure source is suspended, and The controller is further configured to the offer first when the negative pressure source is in activity and indicates and when the negative pressure source is suspended When provide second indicate, wherein it is described second indicate different from described first instruction.

17. equipment according to claim 13, wherein the instruction includes following at least one：Visual instruction, audible finger Show and haptic indication.

18. equipment according to claim 1, wherein the controller is further configured to：

Start the negative pressure source to attempt producing the expectation pressure-reduction level below the dressing；

If the stress level when the very first time, interval was expired below the dressing is not up to the expectation pressure-reduction level, will The negative pressure source disables the second time interval；And

When second time interval is expired, start the negative pressure source and born with attempting the expectation produced below the dressing Voltage levels.

19. equipment according to claim 18, wherein the controller is further configured to the institute below according to the dressing State stress level to be not up to the number of times for expecting pressure-reduction level to change second time interval.

20. equipment according to claim 19, wherein the controller is further configured to turn over second time interval Times, precondition is income value without departing from the second interval threshold.

21. equipment according to claim 18, wherein the controller is further configured to：

When the stress level below the dressing has reached the expectation pressure-reduction level, the negative pressure source is disabled；And

When the stress level below the dressing rises to more than negative threshold, start the negative pressure source, wherein described Expect pressure-reduction level corresponding to than the more negative pressure of the negative threshold.

22. equipment according to claim 1, also including sensor, the sensor is configured to sense under the dressing Side pressure and by the pressure communication for being sensed to the controller.

23. equipment according to claim 1, wherein the negative pressure source is by battery power source energy supply.

A kind of 24. equipment for negative pressure to be applied to wound, including：

Controller, the controller are configured to：

Monitor the dutycycle of the negative pressure source；And

Instruction is provided when the dutycycle exceeds duty cycle threshold；

25. equipment according to claim 24, wherein the dutycycle is reflected in the negative pressure source in a time period being in The time quantum of activity.

26. equipment according to claim 24, wherein the controller is further configured to：

Quantity of the monitoring beyond the dutycycle of the duty cycle threshold；And

The instruction is provided when the quantity of the dutycycle beyond the duty cycle threshold exceeds overloading threshold.

27. equipment according to claim 26, wherein the controller is further configured to monitoring beyond the dutycycle threshold The quantity of the continuous dutycycle of value.

28. equipment according to claim 26, wherein the controller is configured to be monitored beyond institute in the following manner State the quantity of the dutycycle of duty cycle threshold：

29. equipment according to claim 26, wherein the overloading threshold includes 30.

30. equipment according to claim 25, wherein the time period include 1 minute.

31. equipment according to claim 24, wherein the duty cycle threshold includes 9%.

32. equipment according to claim 24, wherein the controller is further configured to, and monitoring per minute is once described to account for Empty ratio.

33. equipment according to claim 24, wherein the controller is further configured to by multiple continuous times Each time period in section determines the dutycycle and monitors the dutycycle when expiring.

34. equipment according to claim 24, wherein the instruction includes disabling the negative pressure source.

35. equipment according to claim 24, wherein the controller is further configured to：

36. equipment according to claim 35, wherein the controller is further configured to the institute below according to the dressing State stress level to be not up to the number of times for expecting pressure-reduction level to change second time interval.

37. equipment according to claim 36, wherein the controller is further configured to turn over second time interval Times, precondition is income value without departing from the second interval threshold.

38. equipment according to claim 35, wherein the controller is further configured to：

39. equipment according to claim 24, also including sensor, the sensor is configured to sense under the dressing Side pressure and by the pressure communication for being sensed to the controller.

40. equipment according to claim 24, also including switch, the switch is constructed such that the controller starts Or disable the negative pressure source.

41. equipment according to claim 24, also including indicator, wherein the controller is configured to when the duty Start the indicator during than exceeding the duty cycle threshold.

42. equipment according to claim 41, wherein the indicator indicates the leakage in the sealing.

43. equipment according to claim 35, wherein the controller is also configured to the dutycycle beyond described Duty cycle threshold and the stress level below the dressing is not up to expected to disable the negative pressure source during pressure-reduction level.

44. equipment according to claim 27, wherein the micropump include it is one of following：Micro-piston pump and it is miniature every Membrane pump.

45. equipment according to claim 24, wherein the negative pressure source is by battery-powered.

46. equipment according to claim 24, wherein the controller is further configured to：

The total time-consuming of monitoring calculating from equipment described in initial start；And

The startup of the negative pressure source is disabled when the total time-consuming reaches lifetime threshold.

47. equipment according to claim 46, wherein the initial start includes the initial start of the negative pressure source.

48. equipment according to claim 46, wherein the lifetime threshold includes 7 days.